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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Hormone Refractory Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with adverse events.

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-006

NCT ID:

NCT00286806

Start Date:

December 2005

Completion Date:

June 2007

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms

Name

Location

New Britain, Connecticut  06052
Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Milwaukee, Wisconsin