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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: ABT-263; Drug: Docetaxel

• Registration Number: NCT00888108
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Study Start: 2009-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel +ABT-263	ABT-263	-
docetaxel +ABT-263	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel.	Weekly
Study the pharmacokinetic interaction of navitoclax (ABT-263) and docetaxel	Weekly
Determine the maximum tolerated dose (MTD) of navitoclax (ABT-263) with a standard regimen of docetaxel	Weekly
Determine the MTD of both navitoclax and docetaxel with a weekly schedule.	Weekly

Secondary Outcome Measures

Name	Time	Method
Evaluate preliminary data regarding objective response rate	Bimonthly
Evaluate preliminary data regarding progression free survival	Bimonthly
Evaluate preliminary data regarding overall survival	Bimonthly
Evaluate preliminary data regarding duration of overall response	Bimonthly
Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status	Bimonthly
Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of docetaxel.	Bimonthly
Evaluate biomarkers	Bimonthly	Define the relationship between disease states, B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy navitoclax when added to a standard and weekly regimen of docetaxel.

Trial Locations

Locations (6)

Site Reference ID/Investigator# 43962; 🇺🇸 Baltimore, Maryland, United States

Site Reference ID/Investigator# 51982; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 20042; 🇳🇱 Rotterdam, Netherlands

Site Reference ID/Investigator# 12844; 🇳🇱 Rotterdam, Netherlands

Site Reference ID/Investigator# 12845; 🇬🇧 Surrey, United Kingdom

Site Reference ID/Investigator# 44182; 🇺🇸 Fort Lauderdale, Florida, United States