Know Cancer

forgot password

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)

Inclusion Criteria:

1. Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to
orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.

2. Patients must have metastatic disease 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. Able to swallow and retain oral medication.

7. Patients enrolled into Cohort B must have documented progression of disease during
treatment with a docetaxel-containing regimen by meeting one or more of the following
criteria- rising PSA, progression of disease per RECIST, or >2 new lesions on bone

8. Patients enrolled into Cohort B must have received at least two cycles of docetaxel.
Minimum doses of prior docetaxel permitted are 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.

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. Prior 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, as judged by the investigator, from prior surgical

8. Concurrent anti-cancer therapy other than docetaxel and prednisone.

9. Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC
(LHRH therapies are acceptable to maintain castrate levels of testosterone)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of AT-101 in combination with docetaxel and prednisone

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

November 2009

Related Keywords:

  • Prostate Cancer
  • at-101
  • at101
  • cancer
  • hormone refractory
  • prostate
  • docetaxel
  • prednisone
  • Prostatic Neoplasms



Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Little Rock, Arkansas  72205-7199
Albuquerque, New Mexico  87131-5636
Charlotte, North Carolina  
Eugene, Oregon  
Charleston, South Carolina