Clinical Trials

Hormone-Refractory Prostate Cancer (HRPC)

Trial Number—AT-101-CS-202

An open-label, multicenter phase I/II trial assessing the safety and efficacy of AT-101, a new treatment for prostate cancer, in combination with docetaxel and prednisone in men with HRPC.

Primary Objective

Secondary Objective

Key Inclusion Criteria

  1. Rising prostate-specific antigen (PSA) levels despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy
  2. Metastatic disease confirmed by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI)
  3. ECOG Performance Status 0 or 1
  4. Adequate hematologic function
  5. Adequate liver and renal function
  6. Ability to swallow and retain oral medication
  7. Patients enrolled into Cohort B (progressed on a docetaxel-containing regimen) must have documented progression using 1 of the following criteria: rising PSA, progression of disease per RECIST, or >2 new lesions on bone scan.
  8. Patients enrolled into Cohort B must have received at least 2 cycles of docetaxel with minimum doses of prior docetaxel of 60 mg/m² on a q 3 week schedule or 20 mg/m² on a weekly schedule.
  9. At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide

Key Exclusion Criteria

  1. Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
  2. Known history of or clinical evidence of central nervous system (CNS) metastases.
  3. Active secondary malignancy or history of other malignancy within the last 5 years.
  4. History of radiation therapy to >/= 25% of the bone marrow.
  5. Peripheral neuropathy of >/= Grade 2
  6. Uncontrolled concurrent illness
  7. Failure to recover fully from prior surgical procedures, as judged by the investigator
  8. Concurrent anticancer therapy other than docetaxel and prednisone
  9. Patients must not be receiving concurrent antiandrogen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone).

Study Design

Phase I - Completed

Phase II - Now enrolling patients into Cohort B. Cohort A is closed.

Cohort Group diagram for NSCLC

Location and Contact Information

For more information on this trial, please contact Ms. Brill or Dr. Leopold using the information provided below.


    Kimberli Brill, BSN           (610) 408-0301     kbrill@ascenta.com
    Lance Leopold, MD         (610) 408-0301     lleopold@ascenta.com


This study is currently being conducted at several study sites within the United States.

Trial Identification Number

NCT00286793

For more information on this trial, please visit www.clinicaltrials.gov