Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen Research (Munich) GmbH
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00788957
First received: October 23, 2008
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Colorectal Cancer Gastrointestinal Cancer Metastatic Colorectal Cancer Rectal Cancer |
Drug: Panitumumab + AMG 102 Drug: Panitumumab + AMG 479 Drug: AMG 479 Drug: AMG 102 Drug: Panitumumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Phase 1: subject incidence of selected adverse events and laboratory abnormalities [ Time Frame: Phase 1: after ~6 subjects enrolled + 1-2 months after the 6th subject is enrolled ] [ Designated as safety issue: Yes ]
- Phase 2: incidence of objective response [ Time Frame: Phase 2: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of response [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Time to response [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Disease control [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Incidence of adverse events and clinical laboratory abnormalities [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: Yes ]
- Incidence of antibody formation to panitumumab, AMG 102, and AMG 479 [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: Yes ]
- Cmin, Cmax, and AUC for panitumumab and AMG 102 [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
- Cmin and Cmax for panitumumab, AMG 102, and AMG 479 [ Time Frame: after ~126 subjects randomized + ~26 months after the 126th subject is randomized ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cohort 3b
Panitumumab arm may cross over to AMG 479
|
Drug: AMG 479
AMG 479
|
| Experimental: Cohort 1 |
Drug: Panitumumab + AMG 102
Panitumumab + AMG 102
|
|
Cohort 3a
Panitumumab arm may cross over to AMG 102
|
Drug: AMG 102
AMG 102
|
| Experimental: Cohort 2 |
Drug: Panitumumab + AMG 479
Panitumumab + AMG 479
|
| Active Comparator: Cohort 3 |
Drug: Panitumumab
Panitumumab (active comparator)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- ECOG 0 or 1
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00788957 History of Changes |
| Other Study ID Numbers: | 20060447 |
| Study First Received: | October 23, 2008 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Canada: Health Canada European Union: European Medicines Agency United States: Food and Drug Administration United States: Quorom Institutional Review Board United States: Western Institutional Review Board |
Keywords provided by Amgen:
|
panitumumab vectibix AMG 102 AMG 479 colon cancer rectal cancer |
colorectal cancer metastatic colorectal cancer EGFR inhibitor IGF inhibitor c-MET inhibitor |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013