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NCT Number: NCT01149720

Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference 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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Premiere Oncology, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tivantinib (ARQ 197) Capsule

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

Other names: Tivantinib

Tivantinib (ARQ 197) Tablet

Drug

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

Other names: Tivantinib

Tivantinib (ARQ 197) Capsule D, oral

Drug

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

Other names: Tivantinib

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 23, 2010
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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