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ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00350051
First received: July 7, 2006
Last updated: October 31, 2014
Last verified: October 2014

July 7, 2006
October 31, 2014
August 2006
September 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
Complete list of historical versions of study NCT00350051 on ClinicalTrials.gov Archive Site
Safety & Tolerability of ZK-Epo plus prednisone [ Time Frame: until progression, unknown duration ] [ Designated as safety issue: Yes ]
Safety & Tolerability of ZK-Epo plus prednisone
Not Provided
Not Provided
 
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: 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.
Experimental: Arm 1
Intervention: Drug: Sagopilone (ZK 219477) + prednisone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
September 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina
 
NCT00350051
91500, 307976
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP