Official Title: “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)”

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: AT-101
  • Oral AT-101 (twice a day on days 1-3 [6 doses] every 21 days). Number of Cycles: 10 cycles or until progression or unacceptable toxicity develops.
• Drug: Docetaxel
  • Docetaxel (75mg/m2 intravenously every 21 days [one cycle]); Number of Cycles: 10 cycles or until progression or unacceptable toxicity develops.
• Drug: Prednisone
  • oral Prednisone (5mg twice a day on days 1-21); Number of Cycles: 10 cycles or until progression or unacceptable toxicity develops.

Primary Measures

• Safety of AT-101 in combination with docetaxel and prednisone
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Preliminary efficacy of AT-101 in combination with docetaxel and prednisone
  • Time Frame: 12 months
    Safety Issue?: No

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 scan.
• 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 procedures.
• 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)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ascenta Therapeutics

Overall Clinical Trial Officials and Contacts

Lance Leopold, MD Study Director Ascenta Therapeutics, Inc.  

Overall Contact: Kimberli Brill, BSN (610) 408-0301 kbrill@ascenta.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00286793

Study ID Number: AT-101-CS-202

ClinicalTrials.gov Identifier: NCT00286793

Health Authority: United States: Food and Drug Administration

Ascenta - Clinical Trials