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Trial record 4 of 46 for:    ARQ 197

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

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ClinicalTrials.gov Identifier: NCT01149720
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : November 2, 2011
Sponsor:
Collaborators:
ArQule
ICON Clinical Research
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Tivantinib (ARQ 197) Capsule Drug: Tivantinib (ARQ 197) Tablet Drug: Tivantinib (ARQ 197) Capsule D, oral Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Arm Intervention/treatment
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
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
Experimental: ARQ 197 Tablet, oral
Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions 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
Other Name: Tivantinib
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
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



Primary Outcome Measures :
  1. Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulation [ Time Frame: 14 days ]
    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).


Secondary Outcome Measures :
  1. Assessment of additional pharmacokinetic parameters of ARQ 197 tablet formulation and capsule C formulation [ Time Frame: 14 days ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149720


Locations
United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
United States, Tennessee
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
United States, Texas
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Daiichi Sankyo, Inc.
ArQule
ICON Clinical Research

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01149720     History of Changes
Other Study ID Numbers: ARQ 197-A-U157
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Daiichi Sankyo, Inc.:
Relative bioavailability
ARQ 197