Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Imetelstat; Motesanib diphosphate; Niacinamide; Paclitaxel; Panitumumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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