Phase II Study of DMXAA (ASA404) in Combination With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Phase 1
Completed
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00832494
- Lead Sponsor
- Antisoma Research
- Brief Summary
This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC.
- Detailed Description
The study was designed to determine the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) non-small cell lung cancer. The phase Ib part of the study evaluated dose levels of DMXAA at 600 mg/m2, 1200 mg/m2 and 1800 mg/m2. In the phase II part of the study, patients were randomized to receive carboplatin and paclitaxel alone or in combination with ASA404 1200 mg/m2. An additional single-arm study was undertaken to evaluate further patients at the 1800 mg/m2 dose level.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of combination Tumor response rate Time to tumor progression Duration of response and stable disease; median and one-year survival
- Secondary Outcome Measures
Name Time Method