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

NCT ID: NCT01149720

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-03-31

Brief Summary

This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.

Conditions

Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARQ 197 Capsule, oral

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

Group Type: EXPERIMENTAL

Tivantinib (ARQ 197) Capsule

Intervention Type: DRUG

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

ARQ 197 Tablet, oral

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

Group Type: EXPERIMENTAL

Tivantinib (ARQ 197) Tablet

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Tivantinib (ARQ 197) Capsule D, oral

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Tivantinib (ARQ 197) Tablet

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Tivantinib; Tivantinib; Tivantinib

Eligibility Criteria

Inclusion Criteria

• Subjects must have a histologically or cytologically confirmed advanced solid tumor at screening.
• Male or female equal or greater than 18 years of age.
• All female subjects of childbearing potential must each have a negative serum pregnancy test result before initiating study treatment.
• An Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
• Adequate bone marrow, liver, and renal function, defined as:

• Platelet count equal or greater than 75 x 10(9)/L
• Hemoglobin (Hb) equal or greater than 9.0 g/dL
• Absolute neutrophil count (ANC) equal or greater than 1.5 x 10(9)/L
• Total bilirubin equal or less than 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal or less than 3 x ULN (equal or less than 5 x ULN for subjects with liver metastases)
• Serum creatinine equal or less than 1.5 x ULN

Exclusion Criteria

• History of cardiac disease: Active coronary artery disease (CAD), defined as myocardial infarction (MI), unstable angina, coronary bypass graft (CABG), or stenting within 6 months prior to study entry (an MI that occurred > 6 months prior to study entry is permitted)
• Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension
• Active, clinically serious infection(s) defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0.
• Known metastatic brain or meningeal tumors, unless the subject is > 3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of first dose of study drug.
• Prior therapy with mesenchymal-epithelial transition factor (c-MET) inhibitors, including ARQ 197.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Premiere Oncology

Santa Monica, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, United States

START - South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ARQ197-A-U157

Identifier Type: -

Identifier Source: org_study_id