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Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles

Outcome Time Frame:

at least 28 days post day 21 of last cycle of treatment

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

91500

NCT ID:

NCT00350051

Start Date:

August 2006

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Metastatic androgen-independent prostate cancer
  • Prostatic Neoplasms

Name

Location

Great Falls, Montana  59405
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Omaha, Nebraska  68114
Baltimore, Maryland  21287
Eugene, Oregon