Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors
Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Paclitaxel in the Treatment of Subjects With Solid Tumors|
- Safety Assessment [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|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
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of Subjects with Solid Tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891605
|United States, Maryland|
|Site Reference ID/Investigator# 22061|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|Site Reference ID/Investigator# 52736|
|Detroit, Michigan, United States, 48202|
|United States, New Jersey|
|Site Reference ID/Investigator# 13421|
|New Brunswick, New Jersey, United States, 08901|
|United States, North Carolina|
|Site Reference ID/Investigator# 12862|
|Durham, North Carolina, United States, 27710|
|Study Director:||Mack Mabry, MD||Abbott|