Status:
COMPLETED
Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
ICON Clinical Research
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01149720
Start Date
July 1 2010
End Date
March 1 2011
Last Update
February 12 2019
Active Locations (4)
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1
Premiere Oncology
Santa Monica, California, United States, 90404
2
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
3
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
4
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229