NCT00888108

Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer

A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Taxotere® (Docetaxel) in the Treatment of Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable disease.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ABT-263	150 mg of ABT-263 is taken orally once daily on Days 1-5 or Days 1-3 of each 21 day cycle. 150 mg of ABT-263 on Days 1-3, 8-10 and 15-17 of each 28-day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
DRUG	Docetaxel	75 mg/m2 will be given by intravenous infusion on day 1 of each 21 -day cycle. 30 mg/m2 will be given by intravenous infusion on day 1, 8, 15 of each 28 -day cycle.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-04-24
• Last updated: 2012-05-22

Locations

6 sites across 3 countries: United States, Netherlands, United Kingdom