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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)

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Treatment

Active

18 and over

Pharmaceutical / Industry

20040153
NCT00094835

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

Diagnosis of unresectable stage IIIB or IV non-small cell lung cancer (NSCLC)
No more than one prior chemotherapy
Adequate hematalogic, 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 brain 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 6 months 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 3 months prior to enrollment
Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

Amgen Call Center

Ph: 866-572-6436

Trial Sites

U.S.A.

Tennessee

Nashville

Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00094835
Information obtained from ClinicalTrials.gov on 2005-02-15

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.