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

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00286793
First received: February 3, 2006
Last updated: June 27, 2011
Last verified: June 2011
  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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ]

Enrollment: 76
Study Start Date: February 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIngle Arm Study of AT-101 in combination with Docetaxel Drug: AT-101
Oral

  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
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, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Kimberli Brill, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00286793     History of Changes
Other Study ID Numbers: AT-101-CS-202
Study First Received: February 3, 2006
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Gossypol acetic acid
Prednisone
Gossypol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Phytogenic
Contraceptive Agents, Female
Spermatocidal Agents

ClinicalTrials.gov processed this record on September 15, 2014