A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Hormone Refractory Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00286806

Run by

Ascenta Therapeutics

People needed

27

Starts

2005-12-01

Expected to finish

2007-06-01

Last updated by the study team

2010-08-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Greenbrae, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Memphis, Tennessee, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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