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

June 27, 2011 updated by: Ascenta Therapeutics

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)

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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
Drug: AT-101
Oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascenta Therapeutics

Investigators

  • Study Director: Lance Leopold, MD, Ascenta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-101-CS-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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