Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

December 11, 2020 updated by: Novartis Pharmaceuticals

A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

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

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Novartis Investigative Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Novartis Investigative Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33075
        • Novartis Investigative Site
      • Colmar Cedex, France, 68024
        • Novartis Investigative Site
      • Lille Cedex, France, 59020
        • Novartis Investigative Site
      • Rouen Cedex, France, 76031
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Novartis Investigative Site
      • Toulouse Cedex 3, France, 31052
        • Novartis Investigative Site
  • Germany
      • Mannheim, Germany, 68135
        • Novartis Investigative Site
      • Weiden, Germany, 92637
        • Novartis Investigative Site
  • Italy
    • MI
      • Milano, MI, Italy, 20133
        • Novartis Investigative Site
      • Milano, MI, Italy, 20141
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
    • Andalucía
      • Malaga, Andalucía, Spain, 29010
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
        • Novartis Investigative Site
  • United States
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego Dept of Moores Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Dept. of Univ. of Colorado
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
        • Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center - Orlando CEPO906A2229
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Marietta, Georgia, United States, 30060
        • NorthWest Georgia Oncology Centers Marietta Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Chicago Hospital StudyCoordinator:CEPO906A2229
    • New York
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University StudyCoordinator:CEPO906A2229

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:

  • Must be ≥ 18 years of age
  • Confirmed and documented diagnosis of prostate cancer
  • Confirmed and documented evidence of progression of disease (hormone refractory)
  • Low testosterone levels
  • Chemotherapy-naïve

Exclusion criteria:

  • Recent radiation therapy (within 4 weeks)
  • Known brain metastasis
  • Peripheral neuropathy
  • Active diarrhea
  • Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
  • Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
Drug: prednisone
Drug: Patupilone
Other Names:
  • EPO906
Experimental: 2: study drug + prednisone days 1 -8
Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid
Drug: prednisone
Drug: Patupilone
Other Names:
  • EPO906
Experimental: 3: Study drug + prednisone days 1 - 4
Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid
Drug: prednisone
Drug: Patupilone
Other Names:
  • EPO906
Active Comparator: 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
Drug: docetaxel
Drug: prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antitumor response based on PSA decrease
Time Frame: Every 3 weeks
Every 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurable soft tissue response for both regimens
Time Frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

Helpful Links

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

September 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2229
  • 2006-001822-23 (EudraCT Number)

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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