ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
NCT ID: NCT00350051
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2006-08-01
2009-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Sagopilone (ZK 219477) + prednisone
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.
Interventions
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Sagopilone (ZK 219477) + prednisone
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Fountain Valley, California, United States
Sarasota, Florida, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Billings, Montana, United States
Omaha, Nebraska, United States
The Bronx, New York, United States
Canton, Ohio, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Fort Worth, Texas, United States
Seattle, Washington, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Countries
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References
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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.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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307976
Identifier Type: OTHER
Identifier Source: secondary_id
91500
Identifier Type: -
Identifier Source: org_study_id
NCT00430222
Identifier Type: -
Identifier Source: nct_alias
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