NCT00073112CompletedPhase 2
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 60
- Locations
- 44
- Primary Endpoint
- Objective Response Rate in subjects with RCC
Study Overview
Brief Summary
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
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
- •Renal Cell Carcinoma.
- •Recurrent tumor.
- •At least 6 weeks post-nephrectomy.
- •Able to tolerate normal activities of daily living.
- •Adequate bone marrow, kidney, and liver function.
Exclusion Criteria
- •Pregnant or breast feeding.
- •Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
- •CNS metastasis.
Outcomes
Primary Outcomes
Objective Response Rate in subjects with RCC
Time Frame: 1 year
Secondary Outcomes
- Time to Tumor Progression (TTP)(1 year)
- Survival(2 years)
- Toxicities associated with treatment administration(1 year)
Investigators
Study Sites (44)
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