Status:
COMPLETED
Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 e...
Eligibility Criteria
Inclusion
- Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
- Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
- ECOG performance status 0 or 1
- Adequate hematologic function
- Adequate liver and renal function
- Able to swallow and retain oral medication.
- 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.
- 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.
- At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
Exclusion
- Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
- Known history of or clinical evidence of central nervous system (CNS) metastases.
- Active secondary malignancy or history of other malignancy within the last 5 years.
- Prior history of radiation therapy to \> 25% of the bone marrow
- Peripheral neuropathy of \> Grade 2
- Uncontrolled concurrent illness
- Failure to recover fully, as judged by the investigator, from prior surgical procedures.
- Concurrent anti-cancer therapy other than docetaxel and prednisone.
- Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00286793
Start Date
February 1 2006
End Date
November 1 2009
Last Update
June 29 2011
Active Locations (13)
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1
Hot Springs, Arkansas, United States
2
Fort Meyers, Florida, United States
3
Chicago, Illinois, United States
4
Fridley, Minnesota, United States