A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

• Status: Terminated
• Trial end date: 2011-08-03
• Target enrollment: 0
• Participant gender: All

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 (Arm C) in subjects with advanced non-squamous NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Imetelstat; Motesanib diphosphate; Niacinamide; Paclitaxel

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

• 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