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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

June 22, 2010
November 1, 2011
July 2010
March 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01149720 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01149720
ARQ 197-A-U157
No
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
  • ArQule
  • ICON Clinical Research
Not Provided
Daiichi Sankyo Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP