Metastatic Hormone Refractory Prostate CancerPhase 2NCT00411528
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
A Phase 2 study testing Patupilone, prednisone and docetaxel in people with Metastatic Hormone Refractory Prostate Cancer, run by Novartis Pharmaceuticals at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone Refractory Prostate Cancer
- What is being tested?
- Patupilone, prednisone and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 32 sitesin 8 countries
- Study dates
- Sep 2006to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States11 sites
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, 80045
University Chicago Hospital StudyCoordinator:CEPO906A2229
Chicago, Illinois, 60637
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
University of California San Diego Dept of Moores Cancer Center
La Jolla, California, 92093-0658
NorthWest Georgia Oncology Centers Marietta Center
Marietta, Georgia, 30060
Norwalk Hospital
Norwalk, Connecticut, 06856
MD Anderson Cancer Center - Orlando CEPO906A2229
Orlando, Florida, 32806
Oregon Health & Science University StudyCoordinator:CEPO906A2229
Portland, Oregon, 97239
H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
Tampa, Florida, 33612
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
France6 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Colmar, 68024
Novartis Investigative Site
Lille, 59020
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Toulouse, 31052
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Valencia, Valencia, 46009
Australia3 sites
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
South Brisbane, Queensland, 4101
Italy3 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Perugia, PG, 06129
Germany2 sites
Novartis Investigative Site
Mannheim, 68135
Novartis Investigative Site
Weiden, 92637
About this study
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
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.
- Being tested
- Patupilone, prednisone, docetaxel
- Keywords
- Prostate Cancer, Hormone Refractory, patupilone, docetaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatupiloneDrug
Also called EPO906
prednisoneDrug
docetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| 1: 8 mg/m2 study drug + prednisone | Experimental | Patupilone 8 mg/m2 + prednisone 5 mg bid daily Receives: Drug: Patupilone; Drug: prednisone |
| 2: study drug + prednisone days 1 -8 | Experimental | 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 Receives: Drug: Patupilone; Drug: prednisone |
| 3: Study drug + prednisone days 1 - 4 | Experimental | 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 Receives: Drug: Patupilone; Drug: prednisone |
| 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily | Active comparator | Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily Receives: Drug: prednisone; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor response based on PSA decrease
Measured: Every 3 weeks
Secondary outcomes (1)
Measurable soft tissue response for both regimens
Measured: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411528
- Sponsor's protocol ID
- CEPO906A2229
- Other IDs
- 2006-001822-23
- Status last verified
- Sep 2020
- First submitted
- 12 Dec 2006
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
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.
PubMed 24722180
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00411528
- Acronym / sponsor ID
- CEPO906A2229
- Keywords
- Prostate Cancer, Hormone Refractory, patupilone, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: 8 mg/m2 study drug + prednisone | Experimental | Drug: Patupilone, Drug: prednisonePatupilone 8 mg/m2 + prednisone 5 mg bid daily |
| 2: study drug + prednisone days 1 -8 | Experimental | Drug: Patupilone, Drug: prednisonePatupilone 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 |
| 3: Study drug + prednisone days 1 - 4 | Experimental | Drug: Patupilone, Drug: prednisonePatupilone 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 |
| 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily | Active comparator | Drug: prednisone, Drug: docetaxelDocetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatupiloneAlso: EPO906 | Drug | 1: 8 mg/m2 study drug + prednisone, 2: study drug + prednisone days 1 -8, 3: Study drug + prednisone days 1 - 4 |
| prednisone | Drug | 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 |
| docetaxel | Drug | 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily |
Primary outcome
Antitumor response based on PSA decrease
Time frame: Every 3 weeks
1 secondary outcome
Measurable soft tissue response for both regimens
Time frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 24722180de 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.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
Related trials for Metastatic Hormone Refractory Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patupilone, prednisone and docetaxel in people with Metastatic Hormone Refractory Prostate Cancer, run by Novartis Pharmaceuticals at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Spain, Australia, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antitumor response based on PSA decrease (time frame: Every 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.