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NCT00325351 Clinical Trial

ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer

Ovarian Neoplasms Clinical Trial

Official title:
Phase 1/2 Study of ZK-Epothilone (ZK-Epo; ZK-219477) in Combination With Carboplatin in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00325351
Other study ID # 91476
Secondary ID 307979
Status Completed
Phase Phase 2
First received
Last updated
Start date August 24, 2006
Est. completion date March 25, 2009

Study information
Verified date April 2021
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

Description:

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is sponsoring this trial.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date March 25, 2009
Est. primary completion date July 8, 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit Exclusion Criteria:- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sagopilone (ZK 219477) + carboplatin
Chemotherapy for recurrent ovarian cancer

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

McMeekin S, Patel R, Verschraegen C, Celano P, Burke J 2nd, Plaxe S, Ghatage P, Giurescu M, Stredder C, Wang Y, Schmelter T. Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer. Br J Cancer. 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Response to treatment with ZK-Epo after 6 cycles After 6 cycles
Secondary Safety and tolerability of ZK-Epo given with carboplatin Sept. 2008
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