Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Diese klinische Studie hat zum Ziel, die maximal verträgliche Dosis und die dosis- limitierenden Nebenwirkungen von BAL101553 zu bestimmen wenn das Medikament dreimal pro Monat (jeweils wöchentlich mit einer Woche Pause) intravenös über 48 Stunden verabreicht wird.
Des weiteren prüfen wir auch die Blutspiegel und Wirksamkeit des Arzneimittels BAL101553. BAL101553 hemmt die Funktion der zellulären Mikrotubuli, und damit die Zellteilung von Tumorzellen. Eine derartige Hemmung der Zellteilung kann das Tumorwachstum verhindern.
Malattie studiate(Fonte di dati: BASEC)
Phase I: fortgeschrittener solider Tumor
Phase IIa: Eierstock-, Eileiter- oder primäres Bauchfellkarzinom oder wiederkehrendes Glioblastom
Health conditions
(Fonte di dati: WHO)
Neoplasms
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Für Phase IIa:
- intravenöse Infusion von BAL101553 während 48 Stunden
Interventions
(Fonte di dati: WHO)
Drug: BAL101553;Drug: BAL101553 at MTD
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Für Phase IIa:
- mindestens 18 Jahre alt
- entweder histologisch nachgewiesenes Eierstock-, Eileiter- oder primäres Bauchfellkarzinom, das platinresisten und refraktär ist, oder histologisch nachgewiesenes, wiederkehrendes Glioblastom
- messbare Tumorerkrankung nach internationalen Richtlinien.
Criteri di esclusione
(Fonte di dati: BASEC)
Für Phase IIa:
- Patienten mit Eierstock-, Eileiter- oder Bauchfellkarzinom, die weniger als 4 Wochen vor Studienstart Chemotheraphie, Radiotherapie, Immuntherapie oder andere Studienbehandlungen bekommen haben
- Patienten mit Glioblastoma, die a) weniger als 12 Wochen vor Studienstart Chemotherapie bekommen haben, b) weniger als 4 Wochen vor Studienstart Chemotherapie bekommen haben oder eine chirurgische Entfernung des Glioblastoms hatten oder c) schon einmal mit Bevacizumab behandelt wurden.
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Age = 18 years
2. Phase 1: Patients with either histologically or cytologically confirmed advanced or
recurrent solid tumor, who failed standard therapy or for whom no effective standard
therapy is available.
Phase 2a: Patients with platinum-resistant/refractory ovarian, fallopian tube or
primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma
histotypes) or glioblastoma in first relapse.
3. Patients with solid tumors must have measurable disease according to Response
Evaluation Criteria in Solid Tumors [RECIST] v1.1.
Patients with recurrent glioblastoma must have measurable disease defined by
contrast-enhancing magnetic resonance imaging.
4. Life expectancy = 12 weeks
5. Acceptable organ and marrow function at baseline (protocol defined laboratory
parameters)
6. Patients with solid tumors must have an Eastern Cooperative Oncology Group (ECOG)
performance status = 1 and patients with recurrent glioblastoma must have an ECOG
performance status = 2.
7. Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
1. Patients with solid tumors who have received chemotherapy, radiotherapy,
immunotherapy, or investigational agents within 4 weeks prior to starting study drug
or who have not recovered from side effects of prior therapies.
Patients with recurrent glioblastoma who have: received radiotherapy within 12 weeks,
unless there is a new area of enhancement consistent with recurrent tumor outside the
radiation field, or there is histological confirmation of unequivocal tumor
progression; received administration of prior antitumor chemotherapy within 4 weeks,
or within 6 weeks for nitrosoureas; undergone surgical resection within 4 weeks or a
stereotactic biopsy/core biopsy within 1 week prior to starting study drug, or have
been treated previously with bevacizumab.
2. Patients who have had prior exposure to BAL101553.
3. Peripheral neuropathy = CTCAE grade 2.
4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or
limit compliance with study requirements
5. Systolic blood pressure (SBP) = 140 mmHg or diastolic blood pressure (DBP) = 90 mmHg
at the screening visit.
6. Blood pressure (BP) combination treatment with more than two antihypertensive
medications.
7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who
are not willing to apply effective birth control.
8. Other protocol-defined exclusion criteria may apply.
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 1/Phase 2
Punti finali primari
(Fonte di dati: WHO)
Maximum Tolerated Dose (MTD) of BAL101553
Punti finali secondari
(Fonte di dati: WHO)
Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication;AUC of BAL101553 and BAL27862;Cmax of BAL101553 and BAL27862;Tmax of BAL101553 and BAL27862;Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1;Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Bellinzona, Berna, Chur, Losanna, San Gallo, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Simon Schäfer
+41 31 389 91 91
trials@sakk.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Thomas Kaindl, MD
Basilea Pharmaceutica
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Thomas Kaindl, MD
Basilea Pharmaceutica
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Ethikkommission Ostschweiz (EKOS)
Data di autorizzazione da parte della commissione d’etica
12.07.2016
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-00707
Secondary ID (Fonte di dati: WHO)
CDI-CS-003
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