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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286806
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
Ascenta Therapeutics

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
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 : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events.

Secondary Outcome Measures :
  1. Complete or partial remission of disease

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286806


Locations
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United States, California
Greenbrae, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
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Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00286806    
Other Study ID Numbers: AT-101-CS-006
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Gossypol acetic acid
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male