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

NCT00350051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-01
Primary Completion
2008-09-24
Completion
2009-12-21

Countries

  • United States
  • Argentina

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00350051 on ClinicalTrials.gov