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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00350051

Collaborator

(none)

Enrollment

Locations

Arm

40.7

Actual Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Sagopilone (ZK 219477) + prednisone	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Sep 24, 2008

Actual Study Completion Date :

Dec 21, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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.

Arm

Intervention/Treatment

Experimental: Arm 1

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.

Outcome Measures

Primary Outcome Measures

PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles [at least 28 days post day 21 of last cycle of treatment]

Secondary Outcome Measures

Safety & Tolerability of ZK-Epo plus prednisone [until progression, unknown duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Fountain Valley	California	United States	92708
2	Sarasota	Florida	United States	34237
3	Baltimore	Maryland	United States	21201
4	Ann Arbor	Michigan	United States	48109
5	Billings	Montana	United States	59101
6	Omaha	Nebraska	United States	68198-7680
7	Bronx	New York	United States	10469
8	Canton	Ohio	United States	44718
9	Portland	Oregon	United States	97201
10	Altoona	Pennsylvania	United States	16601
11	Fort Worth	Texas	United States	76104
12	Seattle	Washington	United States	98108-1597
13	Buenos Aires	Ciudad Auton. De Buenos Aires	Argentina	C1280AEB
14	Buenos Aires		Argentina	1406
15	Buenos Aires		Argentina	C1405DCS
16	Buenos Aires		Argentina	C1416CRJ
17	Córdoba		Argentina	X5016KEH