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Sponsor ID
20060447

Panitumumab Combination Study with Rilotumumab or Ganitumab in Wild-type Kirsten rat sarcoma virus oncogene homolog (KRAS) metastatic colorectal cancer (mCRC)

Sponsor ID
20060447
Clinicaltrials.gov ID
NCT00788957
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.

Additional Study Details

Phase
Phase 1/Phase 2
Product
panitumumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
153
Additional Study Details

Protocol Summary

Primary Outcome Measures

Phase 1: subject incidence of selected adverse events and laboratory abnormalities

Timeframe: Phase 1: after ~6 subjects enrolled + 1-2 months after the 6th subject is enrolled

Phase 2: incidence of objective response

Timeframe: Phase 2: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Secondary Outcome Measures

Duration of response

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Time to response

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Disease control

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Progression-free survival

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Overall survival

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Incidence of adverse events and clinical laboratory abnormalities

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Incidence of antibody formation to panitumumab, AMG 102, and AMG 479

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Cmin, Cmax, and AUC for panitumumab and AMG 102

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Cmin and Cmax for panitumumab, AMG 102, and AMG 479

Timeframe: after ~126 subjects randomized + ~26 months after the 126th subject is randomized

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Colon Cancer
    • Show more
  • Colorectal Cancer
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Oct 2008 - Feb 2012
    Inclusion and Exclusion 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 Response Evaluation Criteria In Solid Tumors (RECIST) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - adequate laboratory values
    Exclusion Criteria:
    - history of central nervous system (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-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor - prior treatment with AMG 102 or AMG 479 - prior treatment with chemotherapy or radiotherapy