Back to resultsA Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
Primary Purpose
Hormone Refractory Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AT-101
Sponsored by
About this trial
This is an interventional treatment trial for Hormone Refractory Prostate Cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Number of participants with adverse events.
Secondary Outcome Measures
Complete or partial remission of disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00286806
Brief Title
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ascenta Therapeutics
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AT-101
Primary Outcome Measure Information:
Title
Number of participants with adverse events.
Secondary Outcome Measure Information:
Title
Complete or partial remission of disease
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Leopold, MD
Organizational Affiliation
Ascenta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Greenbrae
State/Province
California
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
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