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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
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
Overall survival (OS): Time to Death
After 570 death events have been observed (Interim Analysis after 171 death events)or 24 months from last patient enrolled
Time frame: 24 months from last patient enrolled
Progression-Free Survival (PFS)
Randomization to Date of First Documented Disease Progression or Death for up to 24 months from last patient enrolled
Time frame: 24 months from last patient enrolled
Duration of Response
First Response to Disease Progression or Death up to 24 months from last patient enrolled
Time frame: 24 months from last patient enrolled
Objective Response Rate (Complete Response or Partial Response)
Time frame: 37 months
Quality of Life
This is assessed with the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 and EORTC QLQ-LC13 questionnaires
Time frame: 37 months
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