Status:
COMPLETED
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.
Eligibility Criteria
Inclusion
- Rising PSA, as defined by increasing levels on at least two consecutive assessments
- ECOG performance status 0 or 1
- Adequate hematologic function
- Adequate liver and renal function
- Able to swallow and retain oral medication.
Exclusion
- Received prior chemotherapy for HRPC.
- Concurrent therapy for the treatment of prostate cancer.
- Clinical signs or symptoms of CNS metastases
- Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
- Active secondary malignancy or history of other malignancy within the last 5 years.
- Failure to recover from toxicities related to prior therapy.
- Uncontrolled concurrent illness.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00286806
Start Date
December 1 2005
End Date
June 1 2007
Last Update
August 24 2010
Active Locations (4)
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1
Greenbrae, California, United States
2
New Haven, Connecticut, United States
3
Memphis, Tennessee, United States
4
Madison, Wisconsin, United States