Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC

Study Overview
=================
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 either chemotherapy naive or have received and progressed on a docetaxel containing regimen,

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)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: AT-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIngle Arm Study of AT-101 in combination with Docetaxel<br> | Drug: AT-101<br>* Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of AT-101 in combination with docetaxel and prednisone |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy of AT-101 in combination with docetaxel and prednisone |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
at-101, at101, cancer, hormone refractory, prostate, docetaxel, prednisone