Status:
TERMINATED
A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC
Lead Sponsor:
Amgen
Conditions:
Advanced Non-squamous NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2011
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00369070
Start Date
January 31 2007
End Date
August 3 2011
Last Update
January 4 2018
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