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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Patupilone
Treatment: Drugs - prednisone
Treatment: Drugs - docetaxel

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


Treatment: Drugs: Patupilone


Treatment: Drugs: prednisone


Treatment: Drugs: docetaxel
Intervention code [1] 0 0
Treatment: Drugs
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00411528
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00411528