NCT00350051

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Aug 2006

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2009

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

July 7, 2006

Last Update Submit

April 6, 2021

Conditions

Prostate Cancer

Keywords

Prostate cancerMetastatic androgen-independent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety & Tolerability of ZK-Epo plus prednisone

    until progression, unknown duration

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Sagopilone (ZK 219477) + prednisone

Interventions

Sagopilone (ZK 219477) + prednisoneDRUG

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 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

Sarasota, Florida, 34237, United States

Location

Unknown Facility

Baltimore, Maryland, 21201, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Billings, Montana, 59101, United States

Location

Unknown Facility

Omaha, Nebraska, 68198-7680, United States

Location

Unknown Facility

The Bronx, New York, 10469, United States

Location

Unknown Facility

Canton, Ohio, 44718, United States

Location

Unknown Facility

Portland, Oregon, 97201, United States

Location

Unknown Facility

Altoona, Pennsylvania, 16601, United States

Location

Unknown Facility

Fort Worth, Texas, 76104, United States

Location

Unknown Facility

Seattle, Washington, 98108-1597, United States

Location

Unknown Facility

Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB, Argentina

Location

Unknown Facility

Buenos Aires, 1406, Argentina

Location

Unknown Facility

Buenos Aires, C1405DCS, Argentina

Location

Unknown Facility

Buenos Aires, C1416CRJ, Argentina

Location

Unknown Facility

Córdoba, X5016KEH, Argentina

Location

Related Publications (1)

  • Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31.

    PMID: 22850553RESULT

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sagopilonePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

August 1, 2006

Primary Completion

September 24, 2008

Study Completion

December 21, 2009

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

AR(5)US(12)