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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

January 26, 2010

Primary Completion Date

October 12, 2012

Study Completion Date

February 20, 2015

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Tivantinib

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.

DRUG

Placebo

Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.

DRUG

Cetuximab

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.

DRUG

Irinotecan

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.

Trial Locations (40)

11042

Lake Success

13285

Marseille

14263

Buffalo

20089

Milan

21237

Baltimore

21740

Hagerstown

24047

Treviglio

26789

Leer

29210

Columbia

29403

Charleston

32836

Orlando

33435

Boynton Beach

33916

Fort Myers

42100

Reggio Emilia

44718

Canton

45242

Cincinnati

59020

Lille

62801

Centralia

64100

Bayonne

68114

Omaha

68167

Mannheim

70006

Metairie

73104

Oklahoma City

77030

Houston

80528

Fort Collins

81675

München

92024

Encinitas

92501

Riverside

92708

Fountain Valley

98104

Seattle

125367

Moscow

194044

Saint Petersburg

305035

Kursk

357502

Pyatigorsk

372203

Nashville

443031

Samara

454087

Chelyabinsk

90211-1850

Beverly Hills

06360

Norwich

Unknown

Halle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY