Colorectal Cancer Clinical Trial
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
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.
This study consisted of 3 parts:
Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab
to be administered in Part 2.
Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination
with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized
1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab
plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort).
Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded.
Part 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab
monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants
who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease
progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg
rilotumumab or 12 mg/kg ganitumab.
Participants who permanently discontinued all the investigational products completed a
safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of
investigational product. Participants were followed for radiographic disease progression and
survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the
last participant was enrolled in Part 2.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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