Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
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Lead
Daiichi Sankyo
With
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
ICON Clinical Research
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
