Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With 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: NCT00891605|
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: ABT-263 Drug: paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Paclitaxel in the Treatment of Subjects With Solid Tumors|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Experimental: Paclitaxel and ABT-263||
150 mg of ABT-263 is taken orally once daily on Days 1-3 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Other Name: NavitoclaxDrug: paclitaxel
175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle.
Note - The dose and schedule is subject to change based on the toxicities observed.
Other Name: Taxol
- Safety Assessment [ Time Frame: Weekly ]Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel
- Efficacy Assessment [ Time Frame: Bi-monthly ]Evaluate preliminary data regarding objective response rate (ORR), progression free survival (PFS), time to tumor progression (TTP), overall survival (OS), duration of overall response, and, ECOG performance status
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): NCT00891605
|Study Director:||Mack Mabry, MD||Abbott|