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

NCT ID: NCT00325351

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-24

Study Completion Date

2009-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Sagopilone (ZK 219477) + carboplatin

Intervention Type DRUG

Chemotherapy for recurrent ovarian cancer

Interventions

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Sagopilone (ZK 219477) + carboplatin

Chemotherapy for recurrent ovarian cancer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Tucson, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Bakersfield, California, United States

Site Status

La Jolla, California, United States

Site Status

San Diego, California, United States

Site Status

Savannah, Georgia, United States

Site Status

South Bend, Indiana, United States

Site Status

Baltimore, Maryland, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Roanoke, Virginia, United States

Site Status

Calgary, Alberta, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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. 2012 Jan 3;106(1):70-6. doi: 10.1038/bjc.2011.499. Epub 2011 Nov 22.

Reference Type RESULT
PMID: 22108514 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer Healthcare products.

Other Identifiers

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307979

Identifier Type: OTHER

Identifier Source: secondary_id

91476

Identifier Type: -

Identifier Source: org_study_id

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