Study to Evaluate AMG 706 With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Official Title: “An Open-label, Dose-finding Study to Evaluate the Safety and Pharmacokinetics (PK) of AMG 706 With Carboplatin/Paclitaxel, AMG 706 With Panitumumab and AMG 706 With Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)”

The purpose of this trial is: - To characterize the safety profile of AMG 706 when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in subjects with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of AMG 706 when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and AMG 706 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 AMG 706 with CP, AMG 706 with panitumumab, or AMG 706 with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in subjects administered AMG 706 with panitumumab and AMG 706 with CP and panitumumab.

Intervention(s) in this Clinical Trial

• Biological: Panitumumab
  • High affinity fully human IgG2 monoclonal antibody directed against human EGFr.
• Drug: AMG 706
  • Small organic molecule

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Segment B
  • Panitumumab plus AMG 706
• Experimental: Segment A
  • Paclitaxel and carboplatin plus AMG 706.
• Experimental: Segment C
  • Panitumumab and AMG 706 plus carboplatin and paclitaxel

Primary Measures

• To characterize the safety profile of AMG 706 when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in subjects with advanced non-small cell lung cancer (NSCLC).
  • Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
    Safety Issue?: Yes
• To establish the pharmacokinetic (PK) profile of AMG 706 when it is used in combination with CP, with panitumumab, or with CP and panitumumab.
  • Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
    Safety Issue?: Yes

Secondary Measures

• To compare the paclitaxel and AMG 706 PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart.
  • Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
    Safety Issue?: Yes
• To characterize the panitumumab and paclitaxel exposure in the combination regimens of AMG 706 with CP, AMG 706 with panitumumab, or AMG 706 with CP and panitumumab.
  • Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
    Safety Issue?: Yes
• To describe the objective response rate (ORR) in each dose cohort.
  • Time Frame: Nine weeks of treatment
    Safety Issue?: No
• To measure the immunogenicity of panitumumab in subjects administered AMG 706 with panitumumab and AMG 706 with CP and panitumumab.
  • Time Frame: Incidence of anti-panitumumab antibody formation
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Amgen Industry

Overall Clinical Trial Officials and Contacts

MD Study Director Amgen  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00094835

Study ID Number: 20040153

ClinicalTrials.gov Identifier: NCT00094835

Health Authority: United States: Food and Drug Administration

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