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

April 6, 2021 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Bakersfield, California, United States, 93309
      • La Jolla, California, United States, 92093
      • San Diego, California, United States, 92121
    • Georgia
      • Savannah, Georgia, United States, 31404
    • Indiana
      • South Bend, Indiana, United States, 46617
    • Maryland
      • Baltimore, Maryland, United States, 21204
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
    • Virginia
      • Roanoke, Virginia, United States, 24014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sagopilone (ZK 219477) + carboplatin
Chemotherapy for recurrent ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment with ZK-Epo after 6 cycles
Time Frame: After 6 cycles
After 6 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of ZK-Epo given with carboplatin
Time Frame: Sept. 2008
Sept. 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2006

Primary Completion (Actual)

July 8, 2008

Study Completion (Actual)

March 25, 2009

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 12, 2006

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91476
  • 307979 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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