A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

November 8, 2010 updated by: Ascenta Therapeutics

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further Study Details provided by Ascenta.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

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

  • Russian Federation
      • Barnaul, Russian Federation
      • Engels, Russian Federation
      • Kazan, Russian Federation
      • Kursk, Russian Federation
      • Kuzmolovsky, Russian Federation
      • Moscow, Russian Federation
      • Sochi, Russian Federation
      • St. Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Voronezh, Russian Federation
      • Yekaterinburg, Russian Federation
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • New Port Richey, Florida, United States
      • Ocoee, Florida, United States
    • Indiana
      • Fishers, Indiana, United States
    • Minnesota
      • Burnsville, Minnesota, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
      • Las Cruces, New Mexico, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Kettering, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Texas
      • Amarillo, Texas, United States
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Denton, Texas, United States
      • Midland, Texas, United States
      • Paris, Texas, United States
      • Webster, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Kennewick, Washington, United States
      • Vancouver, Washington, 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

All

Description

Inclusion Criteria:

  1. Males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. any T, any N, M1a-c) based on bone scan, CT scan, or MRI scan.

  2. Progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.

    • Progression of measurable disease per RECIST
    • Bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer

    • Rising PSA, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:

      • The assessments are at least one week apart, with the first assessment at least one week later than the reference value
      • Progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
      • The last value prior to study entry is ≥ 2 ng/mL
  3. Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
  4. At least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide
  5. Radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. Strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. The patient must have recovered from all treatment-related toxicities.
  6. ECOG performance status ≤ 2
  7. Able to swallow and retain oral medication

Exclusion Criteria:

  1. Received prior chemotherapy (including estramustine phosphate [Estracyt]) for HRPC. Adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.
  2. Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH directed therapies are acceptable to maintain castrate levels of testosterone).
  3. Treatment with monoclonal antibody (e.g., VEGF targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
  4. Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  5. Active secondary malignancy or history of other malignancy within the last 5 years
  6. Prior history of radiation therapy to ≥ 30% of the bone marrow
  7. Peripheral neuropathy of ≥ Grade 2
  8. Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
  9. Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
  10. Known active symptomatic fungal, bacterial and/or viral infection including active HIV. Note: screening for viruses is not required.
  11. Psychiatric illness/social situations that would limit compliance with the study requirements.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AT-101, prednisone and docetaxel
Drug: AT-101, prednisone and docetaxel
docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
Placebo Comparator: 2
Placebo, prednisone and docetaxel
Drug: placebo, prednisone and docetaxel
docetaxel (75mg/m2 intravenously over 1 hour every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the two treatment arms with respect to overall survival (OS)
Time Frame: 33 months
33 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare progression-free survival (PFS) in men with chemotherapy-naïve metastatic HRPC treated with AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo.
Time Frame: 33 months
33 months
To determine the toxicities associated with oral AT-101 administered in combination with docetaxel and prednisone.
Time Frame: 28 months
28 months
To evaluate PSA and objective tumor response rate.
Time Frame: 28 months
28 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 8, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-101-CS-205

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.

Clinical Trials on Hormone Refractory Prostate Cancer

Clinical Trials on AT-101, prednisone and docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe