ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
NCT00471718 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2012-07-11
Summary
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Conditions
Interventions
- DRUG
-
ABT-751
Phase I: Cohort \| Number of Patients \|Dose (mg) ABT-751 (BID) * -1 \| 3-6 \|100 mg BID * 1 \| 3-6 \|125 mg BID * 2 \| 3-6 \|150 mg BID * 3 \| 3-6 \|175 mg BID * 4 \| 3-6 \|200 mg BID Phase II: Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Vanderbilt-Ingram Cancer Center
lead OTHER
Principal Investigators
-
Jeff Sosman, MD · Vanderbilt-Ingram Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Primary Completion
- 2009-08-31
- Completion
- 2009-08-31
Countries
- United States
Study Locations
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