A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
Phase 2
Withdrawn
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00386555
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- Brief Summary
To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Platinum-pretreated patients with advanced stage IIIb or IV NSCLC
Exclusion Criteria
- Centrally-located tumors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
- Secondary Outcome Measures
Name Time Method Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year) Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel Evaluate the PK of CP 868,596 when given in combination with docetaxel Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373