ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Daiichi Sankyo
Study ID
NCT01075048
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tivantinib — DRUG
    ARQ 197 is supplied as a 120-mg capsule, administered twice daily at the dose determined in the Phase 1 portion of the study. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
  • Placebo — DRUG
    Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
  • Cetuximab — DRUG
    Cetuximab 500 mg/ m\^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
  • Irinotecan — DRUG
    60 minutes after cetuximab, Irinotecan 180 mg/m\^2 intravenous infusion over 30 - 90 minutes. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.

Study Details

ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2. After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

Key Dates

Start date
Jan 26, 2010
Status verified
Mar 2021
Primary completion
Oct 12, 2012
Completion
Feb 20, 2015

Study Design

Enrollment
131 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Tivantinib, cetuximab, irinotecan
    Tivantinib in combination with irinotecan and cetuximab.
  • Placebo Comparator: Phase 2: Placebo, cetuximab, irinotecan
    Placebo in combination with irinotecan and cetuximab
  • Experimental: Phase 1: Tivantinib, cetuximab, irinotecan
    Tivantinib in combination with irinotecan and cetuximab.

Primary Outcome Measure

Progression-Free Survival (PFS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic Therapy [ Time Frame: Baseline up to 80 weeks postdose ]

Locations (24)

FacilityCityStateZIPSite coordinators
-Beverly HillsCalifornia90211-1850-
-EncinitasCalifornia92024-
-Fountain ValleyCalifornia92708-
-RiversideCalifornia92501-
-Fort CollinsColorado80528-
-NorwichConnecticut06360-
-Boynton BeachFlorida33435-
-Fort MyersFlorida33916-
-OrlandoFlorida32836-
-CentraliaIllinois62801-
-MetairieLouisiana70006-
-BaltimoreMaryland21237-
-HagerstownMaryland21740-
-OmahaNebraska68114-
-BuffaloNew York14263-
-Lake SuccessNew York11042-
-CantonOhio44718-
-CincinnatiOhio45242-
-Oklahoma CityOklahoma73104-
-CharlestonSouth Carolina29403-
-ColumbiaSouth Carolina29210-
-NashvilleTennessee372203-
-HoustonTexas77030-
-SeattleWashington98104-

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