Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00788957
First received: October 23, 2008
Last updated: March 26, 2014
Last verified: March 2014
  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 ]

Enrollment: 142
Study Start Date: November 2008
Study Completion Date: October 2013
Primary Completion Date: February 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00788957     History of Changes
Other Study ID Numbers: 20060447
Study First Received: October 23, 2008
Last Updated: March 26, 2014
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:
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 September 30, 2014