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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • Number of participants with adverse events.

Secondary Outcome Measures:
  • Complete or partial remission of disease

Estimated Enrollment: 27
Study Start Date: December 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00286806     History of Changes
Other Study ID Numbers: AT-101-CS-006
Study First Received: February 3, 2006
Last Updated: August 20, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014