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

February 3, 2006
August 20, 2010
December 2005
June 2007   (final data collection date for primary outcome measure)
Number of participants with adverse events.
Safety of single agent AT-101
Complete list of historical versions of study NCT00286806 on ClinicalTrials.gov Archive Site
Complete or partial remission of disease
Preliminary efficacy of single agent AT-101
Not Provided
Not Provided
 
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone Refractory Prostate Cancer
Drug: AT-101
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286806
AT-101-CS-006
Not Provided
Not Provided
Ascenta Therapeutics
Not Provided
Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
Ascenta Therapeutics
August 2010

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