A clinical trial to compare and study the effect of a new experimental drug AMG 706 or Bevacizumab in combination with Paclitaxel and Carboplatin in patients with Advanced Non-Squamous Non-Small Cell Lung Cancer.
- Registration Number
- CTRI/2007/091/000017
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
Measureable disease per RECIST criteria modified
ECOG performance status of 0 or 1
Ability to take oral medications
Competent to give written informed consent
Current or prior history of CNS metastases
Any prior chemotherapy for advanced NSCLC
History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
Prior targeted therapies
Known history of allergy or hypersensitivity to paclitaxel or carboplatin
History of arterial or venous thrombosis within 52 weeks prior to randomization
History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
Peripheral neuropathy > grade 1 per CTCAE Version 3.0
Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
Any kind of disorder that compromises the ability of the subject to comply with the study procedures
Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization
Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
Pregnant or breast feeding women
Known to be HIV, hepatitis B surface antigen, or hepatitis C positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Tumor Response RateTimepoint: Event Based
- Secondary Outcome Measures
Name Time Method Duration of responseTimepoint: Event Based;Overall survivalTimepoint: Death;Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and BTimepoint: Protocol specified timepoints;Progression-free survivalTimepoint: Event Based;Safety and tolerability in the 3 armsTimepoint: Event Based