Spots Global Cancer Trial Database for ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title: A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy
Study ID: NCT01075048
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Phase 1/2 Multicenter study: * Phase 1 portion is open-label to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab. * Phase 2 portion is designed as a randomized, double-blind placebo-controlled study to assess the efficacy and safety of ARQ 197 or matching placebo administered in combination with irinotecan and cetuximab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Beverly Hills, California, United States
, Encinitas, California, United States
, Fountain Valley, California, United States
, Riverside, California, United States
, Fort Collins, Colorado, United States
, Norwich, Connecticut, United States
, Boynton Beach, Florida, United States
, Fort Myers, Florida, United States
, Orlando, Florida, United States
, Centralia, Illinois, United States
, Metairie, Louisiana, United States
, Baltimore, Maryland, United States
, Hagerstown, Maryland, United States
, Omaha, Nebraska, United States
, Buffalo, New York, United States
, Lake Success, New York, United States
, Canton, Ohio, United States
, Cincinnati, Ohio, United States
, Oklahoma City, Oklahoma, United States
, Charleston, South Carolina, United States
, Columbia, South Carolina, United States
, Nashville, Tennessee, United States
, Houston, Texas, United States
, Seattle, Washington, United States
, Bayonne, , France
, Lille cedex, , France
, Marseille cedex, , France
, Halle, , Germany
, Leer, , Germany
, Mannheim, , Germany
, Munchen, , Germany
, Milano, , Italy
, Reggio-Emilia, , Italy
, Treviglio, , Italy
, Chelyabinsk, , Russian Federation
, Kursk, , Russian Federation
, Moscow, , Russian Federation
, Pyatigorsk, , Russian Federation
, Saint-Petersburg, , Russian Federation
, Samara, , Russian Federation
Contact Details
Name: Clinical Study Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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