Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: ABT-263; Drug: paclitaxel

• Registration Number: NCT00891605
• Lead Sponsor: AbbVie

Brief Summary

Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.

Detailed Description

A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of Subjects with Solid Tumors.

Study Timeline

• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Study Start: 2009-07
• Status Verified: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel and ABT-263	paclitaxel	-
Paclitaxel and ABT-263	ABT-263	-

Primary Outcome Measures

Name	Time	Method
Safety Assessment	Weekly	Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel
Efficacy Assessment	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