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


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 10, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00788957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEPanitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRC
Official Title  ICMJEA 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
Brief 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.

Detailed Description 
Study PhasePhase I, Phase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Colon Cancer
  • Colorectal Cancer
  • Gastrointestinal Cancer
  • Metastatic Colorectal Cancer
  • Rectal Cancer
Intervention  ICMJE
  • Drug: Panitumumab + AMG 102
    Panitumumab + AMG 102
  • Drug: Panitumumab + AMG 479
    Panitumumab + AMG 479
  • Drug: AMG 479
    AMG 479
  • Drug: AMG 102
    AMG 102
  • Drug: Panitumumab
    Panitumumab (active comparator)
Study Arms / Comparison Groups
  • Cohort 3b
    Panitumumab arm may cross over to AMG 479
    Intervention: Drug: AMG 479
  • Cohort 1: Experimental
    Intervention: Drug: Panitumumab + AMG 102
  • Cohort 3a
    Panitumumab arm may cross over to AMG 102
    Intervention: Drug: AMG 102
  • Cohort 2: Experimental
    Intervention: Drug: Panitumumab + AMG 479
  • Cohort 3: Active Comparator
    Intervention: Drug: Panitumumab

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE132
Estimated Completion DateDecember 2012
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEUnited States,   Australia,   Austria,   Belgium,   Canada,   France,   Italy,   Poland,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00788957
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20060447
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen