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

This study has been completed.

First Received: February 3, 2006 Last Updated: August 4, 2008 History of Changes

Sponsored by:	Ascenta Therapeutics
Information provided by:	Ascenta Therapeutics
ClinicalTrials.gov Identifier:	NCT00286806

Purpose

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	Intervention	Phase
Hormone Refractory Prostate Cancer	Drug: AT-101	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
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

Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:

Safety of single agent AT-101

Secondary Outcome Measures:

Preliminary efficacy of single agent AT-101

Estimated Enrollment:	27
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286806

Locations

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

Study Director:

Lance Leopold, MD

Ascenta Therapeutics, Inc.

More Information

Additional Information:

Ascenta - Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	AT-101-CS-006
Study First Received:	February 3, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00286806 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Contraceptive Agents
Contraceptive Agents, Female
Urogenital Neoplasms
Genital Diseases, Male
Contraceptive Agents, Male

Hormones
Gossypol acetic acid
Gossypol
Retinol acetate
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Urogenital Neoplasms
Reproductive Control Agents
Contraceptive Agents, Male
Genital Diseases, Male

Gossypol acetic acid
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antispermatogenic Agents
Spermatocidal Agents
Prostatic Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009