Health conditions
(Fonte di dati: WHO)
Non-Small Cell Lung Cancer
Interventions (Fonte di dati: WHO)
Drug: Ceritinib;Drug: pemetrexed;Drug: docetaxel
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell
lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by
the FDA approved Abbott FISH Test.
2. Patient has stage IIIB or IV diagnosis and must have received one or two prior
regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of
locally advanced or metastatic NSCLC.
3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously
irradiated site lesion may only be counted as a target lesion if there is clear sign
of progression since the irradiation
4. Patients must have received previous treatment with crizotinib for the treatment of
locally advanced or metastatic NSCLC.
Exclusion Criteria:
1. Patient with known hypersensitivity to any of the excipients of LDK378
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
magnesium stearate)
2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel
or any known excipients of these drugs.
3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically
unstable or has required increasing doses of steroids within the 2 weeks prior to
screening to manage CNS symptoms.
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Altre informazioni sulla sperimentazione
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)
Punti finali secondari
(Fonte di dati: WHO)
Overall Survival (OS);Overall Response Rate (ORR);Duration of Response (DOR);Disease Control Rate (DCR);Time to Response (TTR);Patient Reported Outcomes (PRO);Time to Definitive Deterioration;Overall Intracranial Response Rate (OIRR);Intracranial Disease Control Rate (IDCR);Duration of Intracranial Response (DOIR)
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
Paesi di esecuzione
(Fonte di dati: WHO)
Belgium, Canada, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Portugal, Republic of, Russian Federation, Singapore, Spain, Switzerland, Turkey, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Contatto per informazioni generali
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Altri numeri di identificazione delle sperimentazioni
Secondary ID (Fonte di dati: WHO)
2012-005637-36
CLDK378A2303
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