CTRI/2007/091/000017
Not yet recruiting
Phase 2
A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer.
Amgen Technology Pvt Ltd0 sites180 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Technology Pvt Ltd
- Enrollment
- 180
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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