A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01063816|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : August 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: veliparib (ABT-888) Drug: carboplatin Drug: gemcitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
|Experimental: Arm 1||
Drug: veliparib (ABT-888)
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.
Other Name: Gemzar
- 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 [ Time Frame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit ]Hematology and Chemistry
- Physical exam including vital signs [ Time Frame: Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit ]Physical exam including blood pressure, pulse and temperature
- Safety assessment: Adverse event assessments [ Time Frame: All study visits ]Collect all adverse events at each visit
- Tumor assessment [ Time Frame: Screening, every nine weeks and Final Visit ]Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063816
|Study Director:||Mark D McKee, MD||AbbVie|