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Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-Type KRAS mCRC
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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20060447 NCT00788957
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Trial Description
Summary This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of AMG 102 or AMG 479 in combination with panitumumab versus panitumumab alone in subjects with metastatic colorectal cancer whose tumors are wild-type KRAS status. Eligibility Criteria Inclusion Criteria: - metastatic adenocarcinoma of the colon or rectum
- wild-type KRAS tumor status
- radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
- measurable disease >/= 20 mm per RECIST
- adequate laboratory values
Exclusion Criteria: - history of CNS metastases
- history of another primary cancer, unless:
- curatively resected non-melanomatous skin cancer
- curatively treated cervical carcinoma in situ
- other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years
- prior treatment with an anti-EGFR, c-MET, and/or IGFR inhibitor
- prior treatment with AMG 102 or AMG 479
- prior treatment with chemotherapy or radiotherapy </= 21 days
- prior treatment with targeted therapy </= 30 days
- known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479
- history of interstitial lung disease
- clinically significant cardiovascular disease </= 1 year
- active inflammatory bowel disease
- known HIV, hepatitis C, or hepatitis B infection
- any co-morbid disease or condition that could increase the risk of toxicity
- serious or non-healing wound </= 35 days
- any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results
- major surgical procedure </= 35 days or minor surgical procedure </= 14 days
- other investigational procedures or drugs </= 30 days
Trial Contact Information
Trial Lead Organizations/Sponsors Amgen, Incorporated MD | | Study Director |
Amgen Call Center | | Ph: 866-572-6436 |
Trial Sites
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U.S.A. |
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South Carolina |
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Greenville |
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Belgium |
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Leuven |
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Spain |
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Barcelona |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00788957 Information obtained from ClinicalTrials.gov on November 28, 2008 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. Back to Top |
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