Clinical trial NCT01149720: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Relative bioavailability
ARQ 197
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
name: ICON Clinical Research
First posted: 2010-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulation
timeFrame: 14 days
Secondary outcomes:
measure: Assessment of additional pharmacokinetic parameters of ARQ 197 tablet formulation and capsule C formulation
timeFrame: 14 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (SCRI)
state: Tennessee
city: San Antonio
country: United States
facility: START - South Texas Accelerated Research Therapeutics, LLC
state: Texas
Study officials:
References: