Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02483104|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: veliparib Drug: carboplatin Drug: paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer|
|Study Start Date :||July 2015|
|Primary Completion Date :||March 2016|
|Study Completion Date :||July 2016|
U.S. FDA Resources
|Experimental: veliparib (ABT-888)||
Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
Other Name: ABT-888Drug: carboplatin
Carboplatin will be administered on Day 1 of each cycle, intravenously.
Other Name: paraplatinDrug: paclitaxel
Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Other Name: taxol
- Number of participants with Dose-limiting toxicities [ Time Frame: During the first cycle (21 days) of veliparib administration ]
- Number of participants with adverse events [ Time Frame: Approximately 5 months ]Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
- Preliminary tumor response [ Time Frame: Participants will be evaluated for 5 months. ]According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- Maximum observed plasma concentration (Cmax) of Veliparib [ Time Frame: For 24 hours following veliparib dosing. ]Maximum observed concentration, occurring at Tmax
- The time to Cmax (peak time, Tmax) of Veliparib [ Time Frame: For 24 hours following veliparib dosing. ]The time at which maximum plasma concentration (Cmax) is observed.
- The area under the plasma concentration-time curve (AUC) of Veliparib [ Time Frame: For 24 hours following veliparib dosing. ]
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): NCT02483104
|Site Reference ID/Investigator# 128815|
|Site Reference ID/Investigator# 128997|
|Site Reference ID/Investigator# 128058|
|Study Director:||Hideyuki Hashiba, BS||AbbVie GK|