Prostate CancerPhase 2NCT00350051
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
A Phase 2 study testing Sagopilone (ZK 219477) + prednisone in people with Prostate Cancer, run by Bayer at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sagopilone (ZK 219477) + prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 1 Aug 2006to 21 Dec 2009
- 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 have evidence of confirmed metastatic prostate cancer
- Serum testosterone must be less than 50 ng/mL
- Disease must be progressing despite anti-androgen therapy
- PSA level must be elevated
- Additional criteria determined at screening visit
Who cannot join
- Any previous cytotoxic chemotherapy for prostate cancer
- Use of any investigational drug in the last 4 weeks
- Symptomatic brain tumors requiring radiation to the brain
- Active infection
- Additional criteria determined at screening visit
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States12 sites
Study site
Altoona, Pennsylvania, 16601
Study site
Ann Arbor, Michigan, 48109
Study site
Baltimore, Maryland, 21201
Study site
Billings, Montana, 59101
Study site
Canton, Ohio, 44718
Study site
Fort Worth, Texas, 76104
Study site
Fountain Valley, California, 92708
Study site
Omaha, Nebraska, 68198-7680
Study site
Portland, Oregon, 97201
Study site
Sarasota, Florida, 34237
Study site
Seattle, Washington, 98108-1597
Study site
The Bronx, New York, 10469
Argentina5 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB
Study site
Buenos Aires, 1406
Study site
Buenos Aires, C1405DCS
Study site
Buenos Aires, C1416CRJ
Study site
Córdoba, X5016KEH
About this study
Official title: Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
Read the detailed description
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
- Conditions
- Prostate Cancer
- Being tested
- Sagopilone (ZK 219477) + prednisone
- Keywords
- Prostate cancer, Metastatic androgen-independent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone (ZK 219477) + prednisoneDrug
Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sagopilone (ZK 219477) + prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
Measured: at least 28 days post day 21 of last cycle of treatment
Secondary outcomes (1)
Safety & Tolerability of ZK-Epo plus prednisone
Measured: until progression, unknown duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study start1 Aug 2006
- Primary completion24 Sep 2008
- Study completion21 Dec 2009
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350051
- Sponsor's protocol ID
- 91500
- Other IDs
- 307976
- Status last verified
- Apr 2021
- First submitted
- 7 Jul 2006
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31.
PubMed 22850553
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00350051
- Acronym / sponsor ID
- 91500
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Metastatic androgen-independent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 24 Sep 2008 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 10 Jul 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 purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
Detailed description
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sagopilone (ZK 219477) + prednisone |
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 have evidence of confirmed metastatic prostate cancer
- Serum testosterone must be less than 50 ng/mL
- Disease must be progressing despite anti-androgen therapy
- PSA level must be elevated
- Additional criteria determined at screening visit
Key exclusion criteria (5 listed)
- Any previous cytotoxic chemotherapy for prostate cancer
- Use of any investigational drug in the last 4 weeks
- Symptomatic brain tumors requiring radiation to the brain
- Active infection
- Additional criteria determined at screening visit
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 |
|---|---|---|
| Sagopilone (ZK 219477) + prednisoneChemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity. | Drug | Arm 1 |
Primary outcome
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
Time frame: at least 28 days post day 21 of last cycle of treatment
1 secondary outcome
Safety & Tolerability of ZK-Epo plus prednisone
Time frame: until progression, unknown duration
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 8 Apr 2021.
- Results publication: PubMed 22850553Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Bayer Study Director study director
Bayer
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sagopilone (ZK 219477) + prednisone in people with Prostate Cancer, run by Bayer at 17 sites in 2 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 5 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Argentina. 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?
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles (time frame: at least 28 days post day 21 of last cycle of treatment). 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 NCT00350051, 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 8 Apr 2021.