Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01149720
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149720
Study Brief:
Protocol Section:
NCT01149720