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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00411528

First received: December 12, 2006

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2006

Last Updated Date

March 7, 2013

Start Date ^ICMJE

September 2006

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antitumor response based on PSA decrease [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Antitumor response based on PSA decrease

Change History

Complete list of historical versions of study NCT00411528 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measurable soft tissue response for both regimens [ Time Frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Measurable soft tissue response for both regimens

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Hormone Refractory Prostate Cancer

Intervention ^ICMJE

Drug: Patupilone

Study Arm (s)

Experimental: 1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily

Intervention: Drug: Patupilone
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

Intervention: Drug: Patupilone
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

Intervention: Drug: Patupilone
Active Comparator: 4: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily

Intervention: Drug: Patupilone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

185

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, France, Germany, Italy, Singapore, Spain

Administrative Information

NCT Number ^ICMJE

NCT00411528

Other Study ID Numbers ^ICMJE

CEPO906A2229, 2006-001822-23

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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