Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors
- Registration Number
- NCT00887757
- Lead Sponsor
- AbbVie
- Brief Summary
This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine +ABT-263 ABT-263 - gemcitabine +ABT-263 gemcitabine -
- Primary Outcome Measures
Name Time Method Assess the safety profile of ABT-263 in combination with gemcitabine. Weekly Study the pharmacokinetic interaction between ABT-263 and gemcitabine. Weekly Determine the maximum tolerated dose (MTD) of ABT-263 in combination with gemcitabine. Weekly
- Secondary Outcome Measures
Name Time Method Evaluate preliminary data regarding progression free survival (PFS) Bi-monthly Evaluate preliminary data regarding objective response rate (ORR) Bi-monthly Evaluate preliminary data regarding time to tumor progression (TTP) Bi-monthly Evaluate preliminary data regarding overall survival (OS) Bi-monthly Evaluate biomarkers to Bi-monthly 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 gemcitabine.
Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of gemcitabine. Bi-monthly Evaluate preliminary data regarding duration of overall response Bi-monthly Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status Bi-monthly