check_circleStudy Completed

Prostate cancer

Bayer Identifier:

91500

ClinicalTrials.gov Identifier:

NCT00350051

EudraCT Number:

Not Available

EU CT Number:

Not Available
ZK-Epo given with prednisone in patients with Metastatic androgen-independent prostate cancer

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - 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
  • - 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 summary

Enrollment Goal
53
Trial Dates
August 2006 - December 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Omaha, 68198-7680, United States
Completed
Seattle, 98108-1597, United States
Completed
Fountain Valley, 92708, United States
Completed
Billings, 59101, United States
Completed
Portland, 97201, United States
Completed
Fort Worth, 76104, United States
Completed
Sarasota, 34237, United States
Completed
Buenos Aires, 1406, Argentina
Completed
Córdoba, X5016KEH, Argentina
Completed
Buenos Aires, C1416CRJ, Argentina
Completed
Ann Arbor, 48109, United States
Completed
Baltimore, 21201, United States
Completed
Canton, 44718, United States
Completed
Altoona, 16601, United States
Completed
Buenos Aires, C1405DCS, Argentina
Completed
Buenos Aires, C1280AEB, Argentina
Completed
Bronx, 10469, United States

Primary Outcome

  • PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
    date_rangeTime Frame:
    at least 28 days post day 21 of last cycle of treatment
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Safety & Tolerability of ZK-Epo plus prednisone
    date_rangeTime Frame:
    until progression, unknown duration
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Phase 2 study of ZK-Epothilone (ZK-Epo; ZK219477) plus prednisone as first-line chemotherapy in patients with metastatic androgen-independent prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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