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

Primary Purpose

Metastatic Hormone Refractory Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Patupilone
prednisone
docetaxel
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Hormone Refractory Prostate Cancer focused on measuring Prostate Cancer, Hormone Refractory, patupilone, docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego Dept of Moores Cancer Center
  • University of Colorado Dept. of Univ. of Colorado
  • Norwalk Hospital
  • Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
  • MD Anderson Cancer Center - Orlando CEPO906A2229
  • H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
  • Palm Beach Cancer Institute
  • NorthWest Georgia Oncology Centers Marietta Center
  • University Chicago Hospital StudyCoordinator:CEPO906A2229
  • Queens Cancer Center of Queens Hospital
  • Oregon Health & Science University StudyCoordinator:CEPO906A2229
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1: 8 mg/m2 study drug + prednisone

2: study drug + prednisone days 1 -8

3: Study drug + prednisone days 1 - 4

4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily

Arm Description

Patupilone 8 mg/m2 + prednisone 5 mg bid daily

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

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

Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily

Outcomes

Primary Outcome Measures

Antitumor response based on PSA decrease

Secondary Outcome Measures

Measurable soft tissue response for both regimens

Full Information

First Posted
December 12, 2006
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00411528
Brief Title
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
Official Title
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Hormone Refractory Prostate Cancer
Keywords
Prostate Cancer, Hormone Refractory, patupilone, docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: 8 mg/m2 study drug + prednisone
Arm Type
Experimental
Arm Description
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
Arm Title
2: study drug + prednisone days 1 -8
Arm Type
Experimental
Arm Description
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
Arm Title
3: Study drug + prednisone days 1 - 4
Arm Type
Experimental
Arm Description
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
Arm Title
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
Arm Type
Active Comparator
Arm Description
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
Intervention Type
Drug
Intervention Name(s)
Patupilone
Other Intervention Name(s)
EPO906
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Antitumor response based on PSA decrease
Time Frame
Every 3 weeks
Secondary Outcome Measure Information:
Title
Measurable soft tissue response for both regimens
Time Frame
Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego Dept of Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
University of Colorado Dept. of Univ. of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
MD Anderson Cancer Center - Orlando CEPO906A2229
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
NorthWest Georgia Oncology Centers Marietta Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University Chicago Hospital StudyCoordinator:CEPO906A2229
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Oregon Health & Science University StudyCoordinator:CEPO906A2229
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novartis Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Novartis Investigative Site
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Novartis Investigative Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 3
ZIP/Postal Code
31052
Country
France
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
Facility Name
Novartis Investigative Site
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06129
Country
Italy
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24722180
Citation
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8483
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
URL
http://www.studyforprostatecancer.com
Description
Prostrate Cancer Study

Learn more about this trial

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

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