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Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer

This study is currently recruiting participants.
Verified by Ascenta Therapeutics, April 2008

Sponsored by: Ascenta Therapeutics
Information provided by: Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00286793
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: AT-101
Drug: Docetaxel
Drug: Prednisone
Phase I
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Docetaxel    Prednisone   

U.S. FDA Resources

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

Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • Safety of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary efficacy of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   65
Study Start Date:   February 2006
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286793

Contacts
Contact: Kimberli Brill, BSN     (610) 408-0301     kbrill@ascenta.com    
Contact: Lance Leopold, MD     (610) 408-0301     lleopold@ascenta.com    

Locations
United States, Arkansas
Recruiting
      Hot Springs, Arkansas, United States
United States, Florida
Recruiting
      Fort Meyers, Florida, United States
United States, Illinois
Recruiting
      Chicago, Illinois, United States
United States, Minnesota
Recruiting
      Fridley, Minnesota, United States
United States, New Mexico
Recruiting
      Albuquerque, New Mexico, United States
United States, New York
Recruiting
      Syracuse, New York, United States
United States, North Carolina
Recruiting
      Wilmington, North Carolina, United States
United States, Oregon
Recruiting
      Portland, Oregon, United States
United States, South Carolina
Recruiting
      Hilton Head Island, South Carolina, United States
United States, Tennessee
Recruiting
      Memphis, Tennessee, United States
Recruiting
      Nashville, Tennessee, United States
Recruiting
      Germantown, Tennessee, United States
United States, Texas
Recruiting
      Richardson, Texas, United States

Sponsors and Collaborators
Ascenta Therapeutics

Investigators
Study Director:     Lance Leopold, MD     Ascenta Therapeutics, Inc.    
  More Information

Ascenta - Clinical Trials  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Ascenta Therapeutics ( Kimberli Brill, Associate Director, Clinical Development )
Study ID Numbers:   AT-101-CS-202
First Received:   February 3, 2006
Last Updated:   April 30, 2008
ClinicalTrials.gov Identifier:   NCT00286793
Health Authority:   United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
gossypol  
at-101  
at101  
cancer  
hormone refractory
prostate
docetaxel
prednisone

Study placed in the following topic categories:
Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Gossypol

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptive Agents, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on September 05, 2008




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