check_circleStudy Completed
Prostate cancer
Bayer Identifier:
91500
ClinicalTrials.gov Identifier:
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
MaleAge
18 YearsTrial summary
Enrollment Goal
53Trial Dates
August 2006 - December 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Sagopilone (BAY86-5302)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 cyclesdate_rangeTime Frame:at least 28 days post day 21 of last cycle of treatmentenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Safety & Tolerability of ZK-Epo plus prednisonedate_rangeTime Frame:until progression, unknown durationenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1