Inserire di nuova l’introduzione

Registro delle sperimentazioni SNCTP con 7638 iscrizioni

In più sono disponibili: 34692 sperimentazioni nei Paesi confinanti


Le sperimentazioni cliniche trasmesse alla piattaforma BASEC sono mostrate in tempo reale su SNCTP dopo il rilascio dell’autorizzazione da parte della commissione d’etica e il via libera dei ricercatori alla loro pubblicazione. In alcuni casi, la pubblicazione su BASEC avviene dopo l’iscrizione in un registro primario internazionale, perciò parte delle iscrizioni può contenere solo informazioni in inglese provenienti dal registro internazionale. Ciò nonostante, i filtri di ricerca riescono ad analizzare tutte le iscrizioni nella banca dati indipendentemente dalla lingua di immissione grazie a un sistema di traduzione automatica.

Lupe (Cerca)Cerca
 
Sperimentazioni trovate 7638

Ordina le sperimentazioni in base a:

Numero di sperimentazioni per pagina

Altre opzioni di visualizzazione delle sperimentazioni trovate

Filtra in base allo stato di reclutamento


PER-051-12 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A PHASE II PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SAFEHER STUDY] (Fonte di dati: WHO)

PER-052-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A Phase IIB, Randomized, Double-blind,Placebo-controlled study to evaluate the neutralization of the interferon gene signature and the clinical efficacy of IFNα-Kinoid in adult subjects with systemic Lupus Erythematosus (Fonte di dati: WHO)

PER-057-14 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

A SINGLE ARM, OPEN-LABEL, LONG-TERM EFFICACY AND SAFETY STUDY OF ROMIPLOSTIM IN THROMBOCYTOPENIC PEDIATRIC SUBJECTS WITH IMMUNE THROMBOCYTOPENIA (ITP) (Fonte di dati: WHO)

PER-060-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 STUDY OF NIVOLUMAB, NIVOLUMAB IN COMBINATION WITH IPILIMUMAB, OR PLACEBO AS MAINTENANCE THERAPY IN SUBJECTS WITH EXTENSIVE-STAGE DISEASE SMALL CELL LUNG CANCER (ED-SCLC) AFTER COMPLETION OF PLATINUM-BASED FIRST LINE CHEMOTHERAPY (Fonte di dati: WHO)

PER-061-14 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

STUDY OF PEMBROLIZUMAB (MK-3475) COMPARED TO PLATINUM-BASED CHEMOTHERAPIES IN PARTICIPANTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MK-3475-042/KEYNOTE-042) (Fonte di dati: WHO)

PER-064-14 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

RANDOMIZED, MULTICENTER, PHASE III,OPEN-LABEL STUDY OF ALECTINIB VERSUSCRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTICLYMPHOMA KINASE−POSITIVE ADVANCEDNON−SMALL CELL LUNG CANCER (Fonte di dati: WHO)

PER-066-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A RANDOMIZED OPEN-LABEL PHASE III STUDY OF SINGLE AGENT PEMBROLIZUMAB VERSUS SINGLEAGENT CHEMOTHERAPY PER PHYSICIAN’S CHOICE FOR METASTATIC TRIPLE NEGATIVE BREAST CANCER(MTNBC) – (KEYNOTE-119) (Fonte di dati: WHO)

PER-067-13 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A PHASE 3 RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF POSACONAZOLE VERSUS VORICONAZOLE FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS (PHASE 3; PROTOCOL NO. MK-5592-069) (Fonte di dati: WHO)

PER-068-13 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

A 52-WEEK TREATMENT, MULTI-CENTER, RANDOMIZED, DOUBLEBLIND,DOUBLE DUMMY, PARALLEL-GROUP, ACTIVE CONTROLLEDSTUDY TO COMPARE THE EFFECT OF QVA149 (INDACATEROL MALEATE/ GLYCOPYRRONIUM BROMIDE) WITH SALMETEROL/FLUTICASONE ONTHE RATE OF EXACERBATIONS IN SUBJECTS WITH MODERATE TO VERYSEVERE COPD (Fonte di dati: WHO)

PER-072-14 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (Fonte di dati: WHO)

Lupe (Cerca)Cerca
 
Sperimentazioni trovate 7638

I risultati mostrati contengono dati provenienti da diverse fonti, che vengono confrontate con il registro delle sperimentazioni cliniche SNCTP; seguono gli ultimi dati aggiornati: BASEC 26.05.2017, WHO 28.05.2017, SNCTP1 (dal 1.1.2014 al 1.12.2016)

Ordina le sperimentazioni in base a:

Numero di sperimentazioni per pagina

Altre opzioni di visualizzazione delle sperimentazioni trovate

Fonte di dati



Filtra in base allo stato di reclutamento


PER-051-12 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A PHASE II PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SAFEHER STUDY] (Fonte di dati: WHO)

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

A PLANNED TOTAL OF APPROXIMATELY 2,500 EVALUABLE PATIENTS WILL BE ENROLLED INTO THE STUDY. THE TRIAL WILL BE CONDUCTED AT APPROXIMATELY 300 CENTRES IN APPROXIMATELY 40 COUNTRIES.
ALL POTENTIAL STUDY PATIENTS MUST PROVIDE SIGNED WRITTEN INFORMED CONSENT (APPROVED BY THE RELEVANT INDEPENDENT ETHICS COMMITTEE [EC]) BEFORE UNDERGOING ANY STUDY-SPECIFIC PROCEDURE. RESULTS OF THE SCREENING ASSESSMENTS MUST BE AVAILABLE AND PATIENTS MUST MEET ALL ELIGIBILITY CRITERIA PRIOR TO ENROLMENT INTO THE STUDY.
ENROLMENT AND THE START OF STUDY MEDICATION (DENOTED AS DAY 1) OCCUR ON THE SAME DAY.
ELIGIBLE PATIENTS WILL BE ALLOCATED TO COHORT A OR B AT THE INVESTIGATORS´ DISCRETION:
• COHORT A (APPROXIMATELY 1,800 PATIENTS): TRASTUZUMAB SC 600MG, ASSISTED ADMINISTRATION INTO THE THIGH OVER A PERIOD OF UP TO 5 MINUTES, USING CONVENTIONAL HANDHELD SYRINGES WITH HYPODERMIC NEEDLES;
COHORT B (APPROXIMATELY 700 PATIENTS): TRASTUZUMAB SC 600MG, FIRST ASSISTED-, THEN SELF-ADMINISTERED INTO THE THIGH OVER A PERIOD OF UP TO 5 MINUTES, USING THE SID. FOR ENROLMENT INTO COHORT B, PATIENTS NEED TO BE WILLING TO SELF-ADMINISTER THE STUDY DRUG BASED ON THE INSTRUCTIONS FOR USE SUPPLIED WITH THE SID AND PERSONAL INSTRUCTIONS PROVIDED BY AN HCP DURING THE FIRST ASSISTED ADMINISTRATION.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: 1. SIGNED WRITTEN INFORMED CONSENT APPROVED BY THE REVIEWING INDEPENDENT ETHICS COMMITTEE (EC)
2. FEMALE OR MALE AGED 18 YEARS OR ABOVE
3. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS 0 OR 1
4. HISTOLOGICALLY CONFIRMED EARLY INVASIVE HER2-POSITIVE CARCINOMA OF THE BREAST WITH NO EVIDENCE OF RESIDUAL, LOCALLY RECURRENT OR METASTATIC DISEASE AND DEFINED AS CLINICAL STAGE I (T1, NO, MO) TO WC (ANY T, N3, MO) THAT IS ELIGIBLE FOR ADJUVANT TREATMENT WITH TRASTUZUMAB
NOTE: PATIENTS TREATED WITHOUT NEOADJUVANT OR ADJUVANT CHEMOTHERAPY, SUCH
AS PATIENTS WITH LOW RISK NODE NEGATIVE TUMOURS1.0 CM, ELDERLY PATIENTS (>65 YEARS OF AGE) OR PATIENTS WITH HER2-POSITIVE EBC BUT DENYING CHEMOTHERAPY, WILL ALSO BE ELIGIBLE TO PARTICIPATE IN THE STUDY, BUT THEIR ENROLMENT WILL BE LIMITED TO APPROXIMATELY 10% OF THE TOTAL STUDY POPULATION.
5. HER2-POSITIVE EBC, DEFINED AS IHC 3+, OR FISH/C1SH POSITIVE, AS DETERMINED IN A LOCAL LABORATORY THAT IS EXPERIENCED/CERTIFIED IN HER2- EXPRESSION TESTING USING AN ACCURATE AND VALIDATED ASSAY
6. SCREENING LEFT VENTRICULAR EJECTION FRACTION (LVEF) 55% AS MEASURED BY ECHOCARDIOGRAPHY, MULTI GATED ACQUISITION (MUGA) SCAN OR MAGNETIC RESONANCE IMAGING (MRI) PER LOCAL PRACTICE

Criteri di esclusione

Exclusion criteria: CANCER RELATED CRITERIA:
1. PREVIOUS NEOADJUVANT OR ADJUVANT BREAST CANCER TREATMENT WITH AN APPROVED OR INVESTIGATIONAL ANTI-HER2 AGENT
2. HISTORY OF OTHER MALIGNANCY WHICH COULD AFFECT COMPLIANCE WITH THE PROTOCOL OR INTERPRETATION OF RESULTS. PATIENTS WITH CURATIVELY TREATED CARCINOMA IN SITU OF THE CERVIX OR BASAL CELL CARCINOMA, AND PATIENTS WITH OTHER CURATIVELY-TREATED MALIGNANCIES WHO HAVE BEEN DISEASE-FREE FOR AT LEAST 5 YEARS, ARE ELIGIBLE.
3. PAST HISTORY OF DUCTAL CARCINOMA IN SITU (DCIS) AND/OR LOBULAR CARCINOMA IN SITU (LCIS) THAT HAS BEEN TREATED WITH ANY SYSTEMIC THERAPY OR WITH RADIATION THERAPY TO THE IPSILATERAL BREAST WHERE INVASIVE CANCER SUBSEQUENTLY DEVELOPS. PATIENTS WHO HAD THEIR DCISILCIS TREATED WITH SURGERY ONLY ARE ALLOWED TO ENTER THE STUDY.
4. METASTATIC DISEASE
5. INADEQUATE BONE MARROW FUNCTION (AS INDICATED BY ANY OF THE FOLLOWING):
. TOTAL WHITE BLOOD CELL COUNT (WBC) < 2,5001 MM3 (<2.5 X 10⁹/L)
. ABSOLUTE NEUTROPHIL COUNT (ANC) < 1,5001 MM3 (< 1.5 X 10⁹/L)
. PLATELETS < 100,000 / MM3 (< 100 X 10⁹/L)
. HAEMOGLOBIN < 10 G/DL
6. IMPAIRED HEPATIC FUNCTION (AS INDICATED BY ANY OF THE FOLLOWING):
. SERUM TOTAL BILIRUBIN > 1.5 X UPPER LIMIT OF NORMAL (ULN)
. ALANINE AMINO TRANSFERASE (ALT) AND/OR ASPARTATE AMINO TRANSFERASE (AST) > 1.25 X ULN
. ALKALINE PHOSPHATASE (ALP) > 2.5 X ULN
PER-052-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A Phase IIB, Randomized, Double-blind,Placebo-controlled study to evaluate the neutralization of the interferon gene signature and the clinical efficacy of IFNα-Kinoid in adult subjects with systemic Lupus Erythematosus (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-M329 Systemic lupus erythematosus, unspecified
Systemic lupus erythematosus, unspecified;Systemic lupus erythematosus, unspecified

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Each patient will receive a dose of 240 mcg of IFN-K/placebo (1.2 mL of study product administered in two injections) at 3 visits during the Induction Period (at Week 0 [Visit 2], Week 1 [Visit 3], and Week 4 [Visit 4]).
Each patient will be administered a dose of 120 mcg of IFN-K/placebo (0.6 mL of study product administered in one injection) at 2 visits during the Maintenance Period (at Week 12 [Visit 6] and Week 24 [Visit 9]). The duration of the intermittent study treatment will be 24 weeks from the first (Week 0 [visit 2]) to the last administration (Week 24 [visit 9]).

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: A patient meeting all of the following inclusion criteria at screening will be eligible for participation in this study:
1.Has had a diagnosis of SLE according to current ACR criteria (4 of 11 ACR criteria) (list of criteria provided in Appendix 1)
2.Has SLEDAI ≥ 6
3.Has at least 1 BILAG A and/or at least 2 BILAG B
4.Has a positive IFN gene signature by RT-qPCR as assessed on a limited number of genes
5.Has anti-nuclear antibodies (ANA) ≥ 1:160 and/or anti-dsDNA antibodies ≥ 7.0 IU/mL
6.Be a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
7.Agrees to receive influenza vaccination during each influenza season of the study period
8.Currently receiving at least one of the following treatment:
•Corticosteroids (CS) at a dose of ≤ 20 mg of prednisone equivalent/day
•Antimalarial drugs (hydroxychloroquine [HCQ] or chloroquine [CQ]); the patient must have been treated since at least 8 weeks and on stable dose for at least 4 weeks prior to first planned administration of the study product
•Methotrexate (MTX); the patient must have been treated since at least 8 weeks and on stable dose (≤ 20 mg/week) for at least 4 weeks prior to the first planned administration of the study product
•Azathioprine (AZA); the patient must have been treated since at least 8 weeks and on stable dose (≤ 2.5 mg/kg/day) for at least 4 weeks prior to the first planned administration of the study product
•Mycophenolate mofetil (MMF), the patient must have been treated since at least 8 weeks and on stable dose (≤ 2 g/day) for at least 4 weeks prior to the first planned administration of the study product
9Study patient and his/her partner has to use effective method of contraception for the duration of the study plus 6 months.
Note: If of child bearing potential, effective contraception methods include:
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first planned administration of the study product. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow up hormone level assessment.Male sterilization (at least 6 months prior to Screening). Combination of the following:
•Oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
•Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, she is considered not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
10.Is able and willing to comply with the requirements of the study protocol (e.g., completion of the diary cards, return for follow-up visits), in the opinion of the Investigator
11.Has provided

Criteri di esclusione

Exclusion criteria: A patient meeting any of the following exclusion criteria at study entry will not be eligible for the study:
1.Has active, severe lupus nephritis as defined either by the immediate need for cyclophosphamide treatment or by renal BILAG A
2.Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A
3.During the 4 months prior to the first planned study product administration, has been treated with corticosteroids (CS) at a dose of >20 mg of prednisone equivalent/day for > 7 consecutive days
4.Is currently receiving or has received pulse dose CS (≥ 250 mg prednisone equivalent/day) within 3 months prior to the first planned administration of the study product.
5.Has received potent immunosuppressive drugs such as cyclophosphamide, cyclosporine A, oral tacrolimus within 3 months prior to the first planned administration of the study product
6.Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy within 6 months prior to the first planned administration of the study product
7.Has received anti-B-cell therapy (e.g., rituximab, epratuzumab) within 12 months prior to the first planned administration of the study product
8.Has significant electrocardiogram (ECG) abnormalities that are clinically relevant and preclude study eligibility in the Investigator’s opinion
9.Has inflammatory joint or skin disease other than SLE that may interfere with study assessments
10.Has any laboratory abnormality other than SLE related that is clinically relevant and precludes study entry in the Investigator’s opinion.
11.Has a history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
12.Has frequent recurrences of oral or genital herpes simplex lesions (≥ 6 occurrences during the 12 months prior to first study product administration)
13.Has had an episode of shingles during the 12 months prior to the first planned administration of the study product
14.Has no IgG against herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
15.Is positive for HTLV 1-2 antibodies, HIV antibodies, Hepatitis C (HCV) antibodies, or Hepatitis B surface antigen (HBsAg)
16.Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
17.Has received any live vaccine within 3 months prior to the first planned administration of the study product (e.g. nasal flu vaccine, oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
18.Has used any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, or any investigational or non-registered vaccine within 30 days prior to the first planned administration of the study product
19.Has a history of chronic alcohol and/or product abuse within 6 months prior to the first planned administration of the study product
20.Is breastfeeding, pregnant, or planning to become pregnant during the study period
21.Has known hypersensitivity to any component of the study
PER-057-14 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

A SINGLE ARM, OPEN-LABEL, LONG-TERM EFFICACY AND SAFETY STUDY OF ROMIPLOSTIM IN THROMBOCYTOPENIC PEDIATRIC SUBJECTS WITH IMMUNE THROMBOCYTOPENIA (ITP) (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-D693 Idiopathic thrombocytopenic purpura-D694 Other primary thrombocytopenia-D695 Secondary thrombocytopenia-D696 Thrombocytopenia, unspecified
Idiopathic thrombocytopenic purpura
Other primary thrombocytopenia
Secondary thrombocytopenia
Thrombocytopenia, unspecified;Idiopathic thrombocytopenic purpura;Other primary thrombocytopenia;Secondary thrombocytopenia;Thrombocytopenia, unspecified

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Romiplostim is supplied in a 5 mL single-use vial as a sterile, white, preservative-free, lyophilized powder containing a protein concentration of 0.5 mg/mL of 10 mM histidine, 4.0% mannitol, 2.0% sucrose, 0.004% polysorbate 20, and a pH 5.0 when reconstituted with 1.2 mL of sterile water for injection. IP will be administered as a subcutaneous injection. The starting dose of romiplostim will be 1 μg/kg based on the subject’s recorded screening weight. Initially, IP will be administered in the clinic by a qualified health care provider and subjects will return to the clinic weekly to provide blood samples for platelet counts and undergo any dose titrations under the supervision of the treating physician. Subjects who receive their first 8 doses in the clinic and achieve a stable dose of romiplostim for at least 4 weeks may be allowed to self-inject romiplostim or have the injection administered by a caregiver. Weekly dose increases will continue in increments of 1 μg/kg up to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of ≥50 x 109/L. Dose adjustments will be allowed to maintain a platelet count between ≥ 50 x 109/L and ≤ 200 x 109/L. Dose adjustments will be evaluated every 12 weeks due to potential body weight changes.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: Inclusion Criteria
4.1.1 Diagnosis of primary ITP according to The American Society of Hematology (ASH) Guidelines (Neunert et al, 2011) at least 6 months before screening, regardless of splenectomy status
4.1.2 Age ≥ 1 year and < 18 years at the time of providing informed consent
4.1.3 Subject must be refractory to a prior ITP therapy, having relapsed after at least 1 prior ITP therapy, or be ineligible for other ITP therapies Examples of prior therapy include but are not limited to: corticosteroids, IVIG, anti-D immunoglobulin, and platelet transfusions. Subjects who have failed a splenectomy are eligible for study participation
4.1.4 Subject has a documented platelet count ≤ 30 x109/L or is experiencing bleeding that is uncontrolled with conventional therapies
4.1.5 Subject’s legally acceptable representative (or subject, if applicable) has provided informed consent before any study-specific procedure; and subject has provided assent, where required by the IRB/IEC

Criteri di esclusione

Exclusion criteria: Exclusion Criteria
4.2.1 Known history of a bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study)
4.2.2 Prior bone marrow transplant or peripheral blood progenitor cell transplant
4.2.3 Known active or prior malignancy except non-melanoma skin cancers within the last 5 years
4.2.4 Known history of myelodysplastic syndrome
4.2.5 Known history of bleeding diathesis
4.2.6 Known history of congenital thrombocytopenia
4.2.7 Known history of hepatitis B, hepatitis C or human immunodeficiency virus
4.2.8 Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
4.2.9 Known history of antiphospholipid antibody syndrome or known positive for lupus anticoagulant
4.2.10 Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
4.2.11 History of venous thromboembolism or thrombotic events
4.2.12 Previous use of romiplostim or eltrombopag
4.2.13 Previous use of PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO) or any other platelet producing agent
4.2.14 Rituximab (for any indication) or 6-mercaptopurine within 8 weeks of enrollment, or anticipated use at any time during the study
4.2.15 Splenectomy within 4 weeks of the screening visit
4.2.16 Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
4.2.17 Vaccinations known to decrease platelet counts within 8 weeks before the screening visit
4.2.18 Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
4.2.19 Subject will have investigational procedures performed while enrolled in
this clinical study
4.2.20 Female subject of child bearing potential (defined as having first menses) is not willing to use, in combination with her partner highly effective methods of birth control during treatment and for 1 month after the end of treatment
4.2.21 Subject is pregnant or breast feeding, or might become pregnant within 1 month after the end of treatment
4.2.22 Subject has known hypersensitivity to any recombinant Escherichia coli derived product (eg, Infergen, Neupogen, somatropin, and Actimmune®)
4.2.23 Subject has previously enrolled into this study
4.2.24 Subject will not be available for protocol-required study visits or procedures, to the best of the subject’s and investigator’s knowledge
4.2.25 Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
PER-060-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 STUDY OF NIVOLUMAB, NIVOLUMAB IN COMBINATION WITH IPILIMUMAB, OR PLACEBO AS MAINTENANCE THERAPY IN SUBJECTS WITH EXTENSIVE-STAGE DISEASE SMALL CELL LUNG CANCER (ED-SCLC) AFTER COMPLETION OF PLATINUM-BASED FIRST LINE CHEMOTHERAPY (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified;Bronchus or lung, unspecified

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Arm A: Nivolumab (Solution for Injection 10mg/mL) 240 mg administered every 2 weeks as a 30 minute Intra-venous infusion.

Arm B: Nivolumab (Solution for Injection 10mg/mL) 1 mg/kg (30 minute Intra-venous infusion) and ipilimumab (Solution for Injection 5mg/mL) 3 mg/kg (90 minute Intra-venous infusion) every 3 weeks for four doses, followed by nivolumab 240 mg every 2 weeks.

Arm C: Placebo for Nivolumab/Ipilimumab (0.9% sodium chloride injection or 5% dextrose injection).

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: 1)Subjects with SCLC documented by histology or cytology.
2)Initial diagnosis with extensive stage disease (Stage IV).
3) ECOG Performance Status 0 or 1.
4)Subjects must have received 4 cycles of platinum-based first line chemotherapy and must have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy.
5) Randomized ≤ 7 weeks from the last dose of platinum-based first line chemotherapy.
6) A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation.

Criteri di esclusione

Exclusion criteria: 1.Subjects with untreated central nervous system metastases are excluded
2.Subjects with active, known, or suspected autoimmune disease are excluded
3.All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
PER-061-14 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

STUDY OF PEMBROLIZUMAB (MK-3475) COMPARED TO PLATINUM-BASED CHEMOTHERAPIES IN PARTICIPANTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MK-3475-042/KEYNOTE-042) (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-C34 Malignant neoplasm of bronchus and lung
Malignant neoplasm of bronchus and lung;Malignant neoplasm of bronchus and lung

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Treatment Gropus
Pembrolizumab (MK-3475) 200 mg intravenous (IV) every 3 weeks (Q3W)
OR
SOC: investigator’s choice of one of the following:
Carboplatin AUC 5 or 6 + paclitaxel 200 mg/m2 Q3W for a maximum of 6 cycles, followed by optional pemetrexed 500 mg/m2 for subjects with non-squamous histologies
Carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 Q3W for a maximum of 6 cycles, followed by optional pemetrexed 500 mg/m2 for subjects with non-squamous histologies
Treatment on study will continue until disease progression, unacceptable adverse events, intercurrent illness that prevents further administration of treatment, investigator’s decision to withdraw the subject, noncompliance with trial treatment or procedures requirements, the subject receives 35 treatments of study medication (pembrolizumab arm only), or administrative reasons. Subjects on the pembrolizumab arm who attain a complete response may consider stopping trial treatment if they meet criteria for holding therapy.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: At least one radiographically measurable lesion per RECIST 1.1.
Be ≥18 years of age
Life expectancy of at least 3 months
Not received prior systemic chemotherapy treatment for their advanced/metastatic NSCLC
Performance status of 0 or 1 (ECOG)
Adequate organ function
No history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer
Provided formalin fixed tumor tissue from a biopsy of a tumor lesion AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiate
Histologically or cytologically confirmed diagnosis of advanced or metastatic
Have a PD-L1 positive tumor as determined by IHC
Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-child bearing potential.
Heterosexually active women are willing to use two methods of birth control (which is also recommended for the female partners of male subjects). The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Subjects should start using birth control from study Visit 1 throughout the study period up to 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents or TKIs
Voluntarily agreed to participate by giving written informed consent

Criteri di esclusione

Exclusion criteria: EGFR sensitizing mutation and/or is EML4/ALK fusion positive
Tumor specimen is not evaluable for PD-L1 expression
Subjects with squamous histology who received carboplatin in combination with paclitaxel
Is receiving systemic steroid therapy < 3 days prior to the first study dose
NSCLC can be treated with curative intent with either surgical resection and/or chemo-radiation
Expected to require any other form of systemic or localized antineoplastic therapy while on trial
Received any prior systemic cytotoxic chemotherapy, biological therapy major surgery within 3week of first study dose: radiation therapy of > 30 Gy within 6 months of the first dose; received palliative radiotherapy of 30Gy or less within 7 days of the first dose.
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Known central nervous system metastases and/or carcinomatous meningitis
Had an allogeneic tissue/solid organ transplant
Active infection, or autoinmune disease
Known history of Human Immunodeficiency Virus, pneumonitis or active Hepatits B or C
Pregnant or breastfeeding, or expecting to conceive or father children
PER-064-14 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

RANDOMIZED, MULTICENTER, PHASE III,OPEN-LABEL STUDY OF ALECTINIB VERSUSCRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTICLYMPHOMA KINASE−POSITIVE ADVANCEDNON−SMALL CELL LUNG CANCER (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-C34 Malignant neoplasm of bronchus and lung
Malignant neoplasm of bronchus and lung;Malignant neoplasm of bronchus and lung

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

The experimental arm will receive alectinib at 600 mg orally twice daily (BID), taken with food.
The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not
amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive
as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK
FISH is required. Both tests will be performed at designated central laboratories.
• Age ≥ 18 years old.
• Life expectancy of at least 12 weeks.
• ECOG PS of 0-2.
• Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not
amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
• Adequate hematologic function:
Platelet count ≥ 100 × 109/L
ANC ≥ 1500 cells/μL
Hemoglobin ≥ 9.0 g/dL
• Adequate renal function:
Calculated creatinine clearance at least 45 mL/min
• Patients must have recovered from effects of any major surgery or significant traumatic
injury at least 28 days before the first dose of study treatment.
• Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
• Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed
incidentally at study baseline. If patients have neurological symptoms or signs due to CNS
metastasis, patients need to complete whole brain radiation or gamma knife irradiation
treatment at least 14 days before enrollment and be clinically stable.
• For all females of childbearing potential, a negative pregnancy test must be obtained within
3 days before starting study treatment.
• For women who are not postmenopausal ( ≥ 12 months of non-therapy-induced amenorrhea)
or surgically sterile (absence of ovaries and/or uterus).

Criteri di esclusione

Exclusion criteria: Patients with a previous malignancy within the past 3 years are excluded (other than
curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by
endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered
to have no impact in PFS and OS for the current NSCLC).
• Any GI disorder that may affect absorption of oral medications, such as mal-absorption
syndrome or status post-major bowel resection.
• Liver disease characterized by:
ALT or AST > 3 × ULN (≥ 5 × ULN for patients with concurrent liver metastasis)
confirmed on two consecutive measurements
OR
Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other
conditions of decompensated liver disease such as coagulopathy, hepatic
encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices
OR
Acute viral or active autoimmune, alcoholic, or other types of hepatitis
• National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding
alopecia), which have not shown improvement and are strictly considered to interfere with
current study medication.
• History of organ transplant.
• Co-administration of anti-cancer therapies other than those administered in this study.
• Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia < 45 beats
per minute.
• Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days
prior to the first dose of study treatment and while on treatment with alectinib or crizotinib
except for oral corticosteroids up to 20 mg of prednisolone equivalent per day
• Administration of agents with potential QT interval prolonging effects within 14 days prior to
the first administration of study drug and while on treatment.
• History of hypersensitivity to any of the additives in the alectinib drug formulation (lactose
monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose,
sodium lauryl sulfate [SLS], magnesium stearate).
• History of hypersensitivity to any of the additives in the crizotinib drug formulation (silica,
colloidal anhydrous cellulose, microcrystalline calcium hydrogen phosphate, anhydrous
sodium starch glycolate, magnesium stearate).
• Pregnant or lactating women.
• Known HIV positivity or AIDS-related illness.
PER-066-15 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A RANDOMIZED OPEN-LABEL PHASE III STUDY OF SINGLE AGENT PEMBROLIZUMAB VERSUS SINGLEAGENT CHEMOTHERAPY PER PHYSICIAN’S CHOICE FOR METASTATIC TRIPLE NEGATIVE BREAST CANCER(MTNBC) – (KEYNOTE-119) (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-C50 Malignant neoplasm of breast
Malignant neoplasm of breast;Malignant neoplasm of breast

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

1. Pembrolizumab: 200 mg IV Q3W
2. Medications used as treatments of physician´s choice (TPC) will be handled according to local regulations and guidelines in participating countries. Sites may choose any ONE drug from the following:
Capecitabine
Eribulin
Gemcitabine
Vinorelbine

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: 1 Have signed informed consent
2 Be ≥18 years of age on day of signing informed consent.
3 Have received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on the most recent therapy.
4 Have been previously treated with an anthracycline and/or taxane in the (neo)adjuvant or metastatic setting
5 Have centrally confirmed mTNBC
6 Have measurable disease based on RECIST 1.1
7 Have provided a newly obtained core or excisional biopsy from a metastatic, notpreviously irradiated, tumor lesion for central determination of triple-negative breast cancer status and PD-L1 biomarker analysis.
8 Have an ECOG performance status of 0 or 1 assessed within 10 days prior of treatment initiation.
9 Demonstrate adequate organ function
10 Female subjects of childbearing potential must have a negative serum pregnancy testwithin 72 hours prior to randomization and agree to use effective contraception. Male subjects should agree to use an adequate method of contraception starting at randomization through at least 120 days after the last dose of
pembrolizumab or TPC, according to local standard of care.

Criteri di esclusione

Exclusion criteria: 1Participated in a study of an investigational agent/device and has received it within 4 weeks of randomization
2 Monoclonal antibody (mAb) for direct anti-neoplastic treatment (4 weeks of randomization)
3 Chemotherapy, targeted small molecule therapy, or radiation therapy (2 weeks of randomization)
4 Not recovered from AE due to previous therapy
5 Active autoimmune disease that required systemic treatment (past 2 years)
6 Diagnosis of immunodeficiency or receiving systemic steroid or immunosuppressive therapy (7 days of randomization)
7 Additional malignancy that progressed or required reatment (last 5 years)
8 Known active brain metastases and/or carcinomatous meningitis
9 Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
10 Active infection requiring systemic therapy
11 History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial
12 Known psychiatric or substance abuse disorders
13 Pregnant or breastfeeding, or expecting to conceive or father children
14 Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor
15 Known history of HIV
16 Known history of Hepatitis B or C
17 Has received a live vaccine (30 days of randomization)
18. Is or has an immediate family member who is part of site staff or sponsor
PER-067-13 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A PHASE 3 RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF POSACONAZOLE VERSUS VORICONAZOLE FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS (PHASE 3; PROTOCOL NO. MK-5592-069) (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-B44 Aspergillosis
Aspergillosis;Aspergillosis

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

At Baseline/Day 1 subjects will be stratified into two strata; high risk or not high risk. Within each stratum, subjects will be randomly assigned to one of two possible treatment arms: POS or VOR for a total duration of therapy of 12 weeks. Subjects will be randomized to POS or VOR in a 1:1 ratio.

Overview of Active Study Drug Dosing by Treatment Arms:
Treatment Arms:
Arm 1- Posaconazole
- IV Therapy* (POS IV): Day 1**: 300 mg BID / Day 2-84: 300 mg QD (solution for injection)
- Oral therapy (POS oral): Day 1**: 300 mg BID / Day 2-84: 300 mg QD (tablets)
Arm 2 – Voriconazole
- IV Therapy* (VOR IV): Day 1**: 6 mg/kg per body weight administered BID / Day 2-84: 4 mg/kg per body weight administered BID (powder for reconstitution)
- Oral theraphy (VOR oral): Day 1**: 300 mg BID / Day 2-84: 200 mg BID (capsules)

* Most subjects begin IV study drug and then step down/transition to oral study drug. If clinically indicated, some subjects may begin study drug with oral therapy instead of IV therapy.
** Day 1 refers to the first day of subject taking either IV or Oral therapy. Subjects will only take one formulation, either IV or oral at a time
IV=intravenous; POS=posaconazole; VOR=voriconazole

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: 1 Each subject must be willing and able to provide written informed consent for the trial.
2 Be ≥13 years of age & weigh >40 kg and ≤150 kg at V2 or between 13 - 14 years & weigh ≥ 50. Either sex and any race/ethnicity
3 Meet the criteria for proven, probable, or possible IA as per 2008 EORTC/MSG disease definitions at V2
4 Subject with possible IA at V2 must be or be in process of an ongoing diagnostic work up which is anticipated to result in mycological diagnosis of proven or probable IA within 7 days postV2
5 Central line in place prior to begin IV study therapy
6 Acute IA
7 Adhere to dosing, study visit schedule & mandatory procedures: study therapy for up to 12 weeks and remain for 3-month follow-up
8 Ability to transition to oral study therapy during the course of the study or to receive the entire 12-week study treatment course IV
9 Fertile female subjects use an accepted method of birth control (MBC) before beginning study-drug treatment and continue its use for 30d after stopping the medication, or have been surgically sterilized. Barrier MBC is necessary if using oral or injectable hormonal contraception. If currently not sexually active, use one of the above methods if they become sexually active while in the study
10 Written IC for the pharmacogenetic testing (if participate in pharmacogenetic analysis)
11 Subject is not taking prohibited antifungal prophylaxis or treatment as defined by the protocol.

Criteri di esclusione

Exclusion criteria: 1Chronic, relapsed/recurrent, or refractory IA which has not responded to prior antifungal treatment (tto)
2 Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
3 Mixed invasive mold fungal and/or invasive Aspergillus fungal infection where either study drug may not be considered active
4 Systemic antifungal therapy for 4 or more consecutive days prior to randomization.
5 IA infection during the receipt of more than 13 days of antifungal prophylaxis
6POS or VOR as empirical tto
7Prohibited tto more recent than washout period
8Condition that may interfere with study
9Hypersensitivity or other serious adverse reaction to azoles
10Female is pregnant or nursing
11History of arrhythmia or infaction
12QTc ≥ 500 msec
13 Liver dysfunction
14 Cirrhosis or Child-Pugh score of C
15 Renal insufficiency or on hemodialysis
16 Galactose intolerance, Lapp lactase deficiency, or GLU-GAL malabsorption
17 Prior acute symptomatic pancreatitis or chronic pancreatitis
18Active skin lesion consistent with squamous cell carcinoma or current or prior history of malignant melanoma
19Artificial ventilation
20Known or suspected Gilbert’s disease
21Tto with medication that cannot be stop and is contraindicated to coadministration of one or more of study drugs
22 Not wxpected to survive for at least 1 week postt-V2
23No prior enrollment in this or other POS study
24Subject or family member is among site or sponsor staff personnel
PER-068-13 | Cambiato: 28.05.2017

Stato di reclutamento

Chiuso

A 52-WEEK TREATMENT, MULTI-CENTER, RANDOMIZED, DOUBLEBLIND,DOUBLE DUMMY, PARALLEL-GROUP, ACTIVE CONTROLLEDSTUDY TO COMPARE THE EFFECT OF QVA149 (INDACATEROL MALEATE/ GLYCOPYRRONIUM BROMIDE) WITH SALMETEROL/FLUTICASONE ONTHE RATE OF EXACERBATIONS IN SUBJECTS WITH MODERATE TO VERYSEVERE COPD (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-J44 Other chronic obstructive pulmonary disease
Other chronic obstructive pulmonary disease;Other chronic obstructive pulmonary disease

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Patients will be assigned to one of the following 2 blinded treatment arms in a ratio of 1:1
1. QVA149 (110/50 μg) once daily
2. Salmeterol/fluticasone (50/500μg) b.i.d
Patients, investigator staff, persons performing the assessments, and data analysts will remain
blind to the identity of the treatment from the time of randomization until database lock, using
the following methods:
(1) Randomization data are kept strictly confidential until the time of unblinding, and will not
be accessible by anyone involved in the study;
(2) The identity of the treatments will be concealed by the use of investigational treatment that
are identical in packaging, labeling, schedule of administration and appearance.
A double-dummy design is used because the identity of the study drugs cannot be disguised
due to their different forms.
Unblinding will only occur in the case of patient emergencies (see Section 5.5.9) and at the
conclusion of the study.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: Written informed consent must be obtained before any assessment is performed.
2. Male or female adults aged ≥40 years.
3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
5. Patients with a post-bronchodilator FEV1 ≥25 and < 60% of the predicted normal value,
and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
(Post refers to 1 h after sequential inhalation of 84 μg (or equivalent dose) of ipratropium
bromide and 400 μg of salbutamol).
6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
required treatment with systemic glucocorticosteroids and/or antibiotics.
7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).

Criteri di esclusione

Exclusion criteria: Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
hCG (human Chorionic Gonadotropin) laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment. Effective contraception methods include.
Patients with Type I or uncontrolled Type II diabetes.
4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101
(Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a
central assessor. These patients should not be re-screened.
5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201.
(These patients should not be re-screened)
6. Patients who have a clinically significant laboratory abnormality at Visit 101.
7. Patients who have clinically significant renal, cardiovascular (such as but not limited to
unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial
infarction), arrhythmia (see below for patients with atrial fibrillation), neurological,
endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
abnormalities which could interfere with the assessment of the efficacy and safety of the
study treatment.
PER-072-14 | Cambiato: 28.05.2017

Stato di reclutamento

Aperto

A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (Fonte di dati: WHO)

Malattie studiate (Fonte di dati: WHO)

-C61 Malignant neoplasm of prostate
Malignant neoplasm of prostate;Malignant neoplasm of prostate

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: WHO)

Investigational product, dose and mode of administration: ODM-201 600 mg or placebo (2 x 300 mg tablets) bid orally with food.
Duration of treatment: Until confirmed metastasis or until death up to 72 months (6 years).
The study treatment will be given in conjunction with the current hormonal treatment, if such treatment has been prescribed to participants. The cost of that treatment will be covered by Sponsor.

Criteri per la partecipazione alla sperimentazione (Fonte di dati: WHO)

Criteri per la partecipazione alla sperimentazione

Inclusion criteria: Among inclusion criteria are the following, please refer to the protocol for the rest of criteria:
1.Written informed consent obtained.
2.Males aged  18 years.
3.Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
4.Progressive castration-resistant prostate cancer is defined as 3 consecutive rising PSA level during androgen deprivation therapy (ADT) at least 1 week apart, resulting in 2 > 50% increases over nadir, with the last value  2 ng/ml despite castrate level of serum testosterone. If the patient has a history of antiandrogen use, the most recent PSA value must be obtained at least 4 weeks after antiandrogen withdrawal.
5.Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Patients who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
6.PSADT of  10 months and PSA  2 ng/ml at screening.
7.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Criteri di esclusione

Exclusion criteria: Among exclusion criteria are the following, please refer to the protocol for the rest of criteria:
1.History of metastatic disease or presence of detectable metastases by blinded central reading. Presence of pelvic lymph nodes < 2 cm in short axis below the aortic bifurcation is allowed.
2.Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer
3.Acute toxicities of prior treatments and procedures not resolved to grade  1 or baseline before randomisation.
4.Prior treatment with:
•second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201, other investigational AR inhibitors,
•CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
•oral ketoconazole longer than for 28 days.
5.Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride) or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before randomisation.
6.Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before randomisation.