Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-Type KRAS mCRC - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00788957

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 I Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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:	December 2012
Estimated Primary Completion Date:	May 2011 (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
Cohort 1: Experimental	Drug: Panitumumab + AMG 102 Panitumumab + AMG 102
Cohort 3a Panitumumab arm may cross over to AMG 102	Drug: AMG 102 AMG 102
Cohort 2: Experimental	Drug: Panitumumab + AMG 479 Panitumumab + AMG 479
Cohort 3: Active Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788957

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, South Carolina
Research Site	Recruiting
Greenville, South Carolina, United States
Belgium
Research Site	Recruiting
Leuven, Belgium
Spain
Research Site	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060447
Study First Received:	October 23, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00788957
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

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009