Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Solid Tumors
Interventions
DRUG

Tivantinib (ARQ 197) Capsule

Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days

DRUG

Tivantinib (ARQ 197) Tablet

Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days

DRUG

Tivantinib (ARQ 197) Capsule D, oral

Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase

Trial Locations (4)

33916

Florida Cancer Specialists, Fort Myers

37203

Sarah Cannon Research Institute (SCRI), Nashville

78229

START - South Texas Accelerated Research Therapeutics, LLC, San Antonio

90404

Premiere Oncology, Santa Monica

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

INDUSTRY

collaborator

ICON Clinical Research

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY