Status:
COMPLETED
Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Amgen
Conditions:
Lung Cancer
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with ...
Detailed Description
This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patie...
Eligibility Criteria
Inclusion
- Diagnosis of unresectable stage IIIB or IV non-small cell lung cancer (NSCLC)
- No more than one prior chemotherapy
- Adequate hematologic, renal and hepatic function
- Measurable disease or evaluable disease on CAT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to fast for 10 hrs twice during the study - Able to tolerate oral medications
- Life expectancy of at least 3 months
Exclusion
- Symptomatic or untreated central nervous system metastases requiring current treatment
- History of arterial thrombosis within 1 year prior to enrollment
- Anticoagulant therapy, except for warfarin of less than 2mg per day
- Symptomatic peripheral neuropathy
- History of pulmonary hemorrhage or hemoptysis
- Myocardial infarction within 1 year before enrollment
- Uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\]
- History of other cancer, unless treated with no known active disease for longer than 3 years
- Previous treatment with AMG 706 or panitumumab, previous treatment with inhibitors of VEGF or EGF
- No antibody treatment for 6 weeks prior to enrollment
- Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00094835
Start Date
January 1 2005
End Date
March 1 2007
Last Update
March 24 2016
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