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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-05-01
• Completion: 2018-01-01
• First posted: 2012-03-27
• Last updated: 2012-08-15