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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00411528




Registration number
NCT00411528
Ethics application status
Date submitted
12/12/2006
Date registered
14/12/2006
Date last updated
17/12/2020

Titles & IDs
Public title
Efficacy and Safety of Patupilone in Men (=18 Years) With Metastatic Hormone Refractory Prostate Cancer
Scientific title
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer
Secondary ID [1] 0 0
2006-001822-23
Secondary ID [2] 0 0
CEPO906A2229
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone Refractory Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1: 8 mg/m2 study drug + prednisone - Patupilone 8 mg/m2 + prednisone 5 mg bid daily

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

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

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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Antitumor response based on PSA decrease
Timepoint [1] 0 0
Every 3 weeks
Secondary outcome [1] 0 0
Measurable soft tissue response for both regimens
Timepoint [1] 0 0
Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux Cedex
Country [12] 0 0
France
State/province [12] 0 0
Colmar Cedex
Country [13] 0 0
France
State/province [13] 0 0
Lille Cedex
Country [14] 0 0
France
State/province [14] 0 0
Rouen Cedex
Country [15] 0 0
France
State/province [15] 0 0
Strasbourg
Country [16] 0 0
France
State/province [16] 0 0
Toulouse Cedex 3
Country [17] 0 0
Germany
State/province [17] 0 0
Mannheim
Country [18] 0 0
Germany
State/province [18] 0 0
Weiden
Country [19] 0 0
Italy
State/province [19] 0 0
MI
Country [20] 0 0
Italy
State/province [20] 0 0
PG
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Spain
State/province [22] 0 0
Andalucía
Country [23] 0 0
Spain
State/province [23] 0 0
Catalunya
Country [24] 0 0
Spain
State/province [24] 0 0
Comunidad Valenciana
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00411528