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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:July 2010
End Date:March 2011

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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.


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.
We found this trial at
4
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San Antonio, TX
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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Fort Myers, FL
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2020 Santa Monica Blvd
Santa Monica, California 90404
310-633-8400
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Santa Monica, CA
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Nashville, Tennessee 37203
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Nashville, TN
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