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

• Sponsor: Ascenta Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00286806
• Collaborator: (none)
• Enrollment: 27
• Locations: 4
• Duration (Months): 18
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Refractory Prostate Cancer	Drug: AT-101	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events. []

Secondary Outcome Measures

1. Complete or partial remission of disease []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Rising PSA, as defined by increasing levels on at least two consecutive assessments

2. ECOG performance status 0 or 1

3. Adequate hematologic function

4. Adequate liver and renal function

5. Able to swallow and retain oral medication.

Exclusion Criteria:

1. Received prior chemotherapy for HRPC.

2. Concurrent therapy for the treatment of prostate cancer.

3. Clinical signs or symptoms of CNS metastases

4. Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.

5. Active secondary malignancy or history of other malignancy within the last 5 years.

6. Failure to recover from toxicities related to prior therapy.

7. Uncontrolled concurrent illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Greenbrae	California	United States
2		New Haven	Connecticut	United States
3		Memphis	Tennessee	United States
4		Madison	Wisconsin	United States

Sponsors and Collaborators

• Ascenta Therapeutics

Investigators

• Study Director: Lance Leopold, MD, Ascenta Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00286806
• Other Study ID Numbers: AT-101-CS-006
• First Posted: Feb 6, 2006
• Last Update Posted: Aug 24, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Prostatic Neoplasms; Gossypol acetic acid

Study Results

No Results Posted as of Aug 24, 2010