Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Etoposide phosphate

Obatoclax

Enzyme Inhibitors

Obatoclax Mesylate:

30 mg fixed dose;administered IV on days 1-3 every 21 days for 6 cycles. Maintenance therapy (optional and only if documented CR or PR) with obatoclax mesylate is administered at the same IV dose on days 1-3 every 21 days until disease progression or death.

Carboplatin:

Dose targeted at AUC of 5; administered IV on Day 1 only every 21 days for 6 cycles

Etoposide:

100mg/m2 administered IV on Days 1-3 every 21days for 6 cycles

Obatoclax Mesylate, Carboplatine and Etoposide

Carboplatin:

Dose targeted at AUC of 5 administered IV on Day 1 only every 21 days for 6 cycles.

Etoposide:

100mg/m2 administered IV on Days 1-3 every 21 days for 6 cycles

Carboplatin and Etoposide

This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer.

Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer

A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer

After 570 death events have been observed (Interim Analysis after 171 death events)or 24 months from last patient enrolled

Randomization to Date of First Documented Disease Progression or Death for up to 24 months from last patient enrolled

First Response to Disease Progression or Death up to 24 months from last patient enrolled

This is assessed with the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 and EORTC QLQ-LC13 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer	NCT01563601	Extensive-stage...	Obatoclax Mesyl... Carboplatin and...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer	NCT01563601	Extensive-stage...	Obatoclax Mesyl... Carboplatin and...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for obatoclax mesylate, carboplatine and etoposide