The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.
Carboplatin will be dosed on Day 1 of each cycle, intravenously.
Dosing on Days 1 and 8 of each Cycle, intravenously.
Determine the maximum tolerated dose and recommended Phase 2 dose
Time frame: ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).
Pharmacokinetics Area Under the Curve (AUC)
Time frame: Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose
Safety assessment: Electrocardiogram
Time frame: Screening, Day 8 of each Cycle of drug and Final Visit
Safety assessment: Clinical Laboratory Tests
Hematology and Chemistry
Time frame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Physical exam including vital signs
Physical exam including blood pressure, pulse and temperature
Time frame: Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
Safety assessment: Adverse event assessments
Collect all adverse events at each visit
Time frame: All study visits
Tumor assessment
Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
Time frame: Screening, every nine weeks and Final Visit
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