CompletedPhase 2

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

United States53 participantsStarted 2006-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Trial details

NCT IDNCT00350051

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09-24

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