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

This study has been completed.

Sponsor:

Collaborators:

ArQule

ICON Clinical Research

Information provided by (Responsible Party):

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT01149720

First received: June 22, 2010

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 22, 2010
Last Updated Date	November 1, 2011
Start Date ^ICMJE	July 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2010)	Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulation [ Time Frame: 14 days ] [ Designated as safety issue: No ] The primary endpoints are the area under the concentration time curve from time of dosing until 12 hours post-dose (AUC0-12) and maximum observed concentration in plasma (Cmax) of ARQ 197 following the administration of the tablet (fed conditions) and capsule formulation (at least 1 hour before or 2 hours after a meal).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01149720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 22, 2010)	Assessment of additional pharmacokinetic parameters of ARQ 197 tablet formulation and capsule C formulation [ Time Frame: 14 days ] [ Designated as safety issue: No ] Time until Cmax (tmax), apparent oral clearance (CL/F), and apparent volume of distribution (V/F) of ARQ 197, and if possible, minimum observed concentration (Cmin) and average observed concentration (Cavg) following the administration of the tablet (fed conditions) and capsule formulation (at least 1 hour before or 2 hours after a meal)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
Official Title ^ICMJE	An Open-Label, Phase 1, Randomized, Two-Treatment, Two-Period, Two-Way Crossover, Relative Bioavailability Study Of A Capsule And A Tablet Formulation Of ARQ 197 In Subjects With Advanced Solid Tumors
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Solid Tumors
Intervention ^ICMJE	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 Other Name: Tivantinib Drug: Tivantinib (ARQ 197) Tablet Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days Other Name: Tivantinib 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 Other Name: Tivantinib
Study Arm (s)	Experimental: 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 Intervention: Drug: Tivantinib (ARQ 197) Capsule Experimental: ARQ 197 Tablet, oral Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days Intervention: Drug: Tivantinib (ARQ 197) Tablet Experimental: 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: Drug: Tivantinib (ARQ 197) Capsule D, oral
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	24
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01149720
Other Study ID Numbers ^ICMJE	ARQ 197-A-U157
Has Data Monitoring Committee	No
Responsible Party	Daiichi Sankyo Inc.
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	ArQule ICON Clinical Research
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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