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

This study has been completed.

Sponsor:

Information provided by:

Ascenta Therapeutics

ClinicalTrials.gov Identifier:

NCT00286806

First received: February 3, 2006

Last updated: August 20, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2006

Last Updated Date

August 20, 2010

Start Date ^ICMJE

December 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participants with adverse events.

Original Primary Outcome Measures ^ICMJE

Safety of single agent AT-101

Change History

Complete list of historical versions of study NCT00286806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Complete or partial remission of disease

Original Secondary Outcome Measures ^ICMJE

Preliminary efficacy of single agent AT-101

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hormone Refractory Prostate Cancer

Intervention ^ICMJE

Drug: AT-101

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00286806

Other Study ID Numbers ^ICMJE

AT-101-CS-006

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Ascenta Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lance Leopold, MD

Ascenta Therapeutics, Inc.

Information Provided By

Ascenta Therapeutics

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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