NCT00486538CompletedPhase 2
An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib
AbbVie (prior sponsor, Abbott)13 sites in 2 countries53 target enrollmentStarted: June 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 13
- Primary Endpoint
- Objective Response Rate
Study Overview
Brief Summary
This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single arm
Experimental
One oral dose daily
Intervention: ABT-869 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: From randomization until patient death or alive at 2 years
Secondary Outcomes
- Progression-free rate(Week 16)
- Best response rate(From randomization until patient death or alive at 2 years)
- Time to tumor progression(From randomization until patient death or alive at 2 years)
- Progression free survival(Radiographic evaluation every month, clinical evaluation every 4 weeks)
- Overall Survival(Two-year follow-up post study)
Investigators
Study Sites (13)
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