Conditions: Colorectal Cancer
Keywords: GSI Gilead Gilead Sciences GS-6624 Colorectal Cancer KRAS Oncology monoclonal antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 266
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

Detailed description:

Arms:
arm 1: Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 2: Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 3: Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 4: Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Interventions: intervention 1: Simtuzumab intervention 2: Placebo to match SIM intervention 3: Leucovorin intervention 4: Irinotecan intervention 5: Fluorouracil
Intervention descriptions: intervention 1: SIM administered via intravenous infusion over 30 minutes intervention 2: Placebo to match SIM administered via intravenous infusion over 30 minutes intervention 3: l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours intervention 4: Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes intervention 5: Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Protocol document: