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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286793
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : June 29, 2011
Information provided by:
Ascenta Therapeutics

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,

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: AT-101 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: SIngle Arm Study of AT-101 in combination with Docetaxel Drug: AT-101

Primary Outcome Measures :
  1. Safety of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Preliminary efficacy of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286793

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United States, Arkansas
Hot Springs, Arkansas, United States
United States, Florida
Fort Meyers, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Syracuse, New York, United States
United States, North Carolina
Wilmington, North Carolina, United States
United States, Oregon
Portland, Oregon, United States
United States, South Carolina
Hilton Head Island, South Carolina, United States
United States, Tennessee
Germantown, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Richardson, Texas, United States
Sponsors and Collaborators
Ascenta Therapeutics
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Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
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Responsible Party: Kimberli Brill, Associate Director, Clinical Development, Ascenta Therapeutics Identifier: NCT00286793    
Other Study ID Numbers: AT-101-CS-202
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011
Keywords provided by Ascenta Therapeutics:
hormone refractory
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Gossypol acetic acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male