- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00286806
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
August 20, 2010 updated by: Ascenta Therapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
27
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Greenbrae, California, United States
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Connecticut
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New Haven, Connecticut, United States
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Tennessee
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Memphis, Tennessee, United States
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Wisconsin
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Madison, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of participants with adverse events.
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Secondary Outcome Measures
Outcome Measure |
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Complete or partial remission of disease
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lance Leopold, MD, Ascenta Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 3, 2006
First Posted (Estimate)
February 6, 2006
Study Record Updates
Last Update Posted (Estimate)
August 24, 2010
Last Update Submitted That Met QC Criteria
August 20, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Contraceptive Agents, Male
- Spermatocidal Agents
- Antispermatogenic Agents
- Gossypol acetic acid
Other Study ID Numbers
- AT-101-CS-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hormone Refractory Prostate Cancer
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University of California, IrvineBristol-Myers SquibbCompletedRecurrent Prostate Cancer | Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Hormone-refractory Prostate CancerUnited States
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DendreonCompletedHormone Refractory Prostate Cancer | Castration-resistant Prostate Cancer | Prostate Cancer MetastaticUnited States
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Jiangsu HengRui Medicine Co., Ltd.UnknownHormone Refractory Prostate Cancer | Metastatic Prostate CarcinomaChina
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National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Hormone-refractory Prostate CancerUnited States
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PfizerAstellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.CompletedProstate Cancer | Hormone Refractory Prostate CancerUnited States
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Spanish Oncology Genito-Urinary GroupAstellas Pharma Inc; Apices Soluciones S.L.CompletedHormone-refractory Prostate CancerSpain
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Peking UniversityWithdrawnHormone Refractory Prostate CancerChina
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Tianjin Medical University Cancer Institute and...UnknownHormone Refractory Prostate CancerChina
-
CytoVac A/SCompletedHormone-refractory Prostate CancerDenmark
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British Columbia Cancer AgencyCompletedHormone Refractory Prostate CancerCanada
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H. Lee Moffitt Cancer Center and Research InstituteMinneamrita Therapeutics LLCTerminatedAcute Myeloid LeukemiaUnited States
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Brigham and Women's HospitalRecruiting