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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2012

Primary Completion Date

May 31, 2016

Study Completion Date

January 31, 2018

Conditions
Extensive-stage Small Cell Lung Cancer
Interventions
DRUG

Obatoclax Mesylate, Carboplatine and Etoposide

"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"

DRUG

Carboplatin 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"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT01563601 - 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 | Biotech Hunter | Biotech Hunter