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Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer

NCT ID: NCT00246688

Last Updated: 2015-12-31

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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability.

Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sagopilone, 0.5 h infusion

Subjects received one infusion (for 0.5 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Group Type EXPERIMENTAL

Sagopilone (BAY86-5302 , ZK219477)

Intervention Type DRUG

10.5 mg lyophilized sagopilone per vial

Sagopilone, 3 h infusion

Subjects received one infusion (for 3 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Group Type EXPERIMENTAL

Sagopilone (BAY86-5302 , ZK219477)

Intervention Type DRUG

10.5 mg lyophilized sagopilone per vial

Interventions

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Sagopilone (BAY86-5302 , ZK219477)

10.5 mg lyophilized sagopilone per vial

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:- Females aged 18 or over - Cancer of any of the following types: -- epithelial ovarian cancer -- peritoneal cavity cancer -- fallopian tube cancer - Up to 2 previous chemotherapies; the most recent must have been a platinum- containing therapy - Progression of disease or symptomatic relapse during, or within 6 months of previous therapy - 4 weeks or more since prior radiotherapy or chemotherapy - 3 weeks or more since prior immunotherapy - Adequate recovery from previous surgery, radiotherapy, and chemotherapy ( excluding alopecia) - Survival expectation of 3 months or more Exclusion Criteria: - More than 2 previous chemotherapies - Previous treatment with epothilones - Use of any investigational drug within 4 weeks of start of study treatment or inadequate recovery from any toxic effects of such therapy - Previous radiation to the whole pelvis - Symptomatic brain metastases requiring whole-brain irradiation - Active infection - Any other malignancy except: -- Non-melanoma skin cancer -- Carcinoma in situ of cervix -- Malignancy with treatment 5 or more years ago without relapse - Mixed mesodermal tumor - Prior hormone therapy for any malignancy in the previous month - Women of childbearing potential
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

Countries

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United Kingdom

References

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Rustin G, Reed N, Jayson GC, Ledermann JA, Adams M, Perren T, Poole C, Lind M, Persic M, Essapen S, Gore M, Calvert H, Stredder C, Wagner A, Giurescu M, Kaye S. A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer. Ann Oncol. 2011 Nov;22(11):2411-2416. doi: 10.1093/annonc/mdq780. Epub 2011 Mar 3.

Reference Type RESULT
PMID: 21372124 (View on PubMed)

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2005-000635-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

307970

Identifier Type: -

Identifier Source: secondary_id

91447

Identifier Type: -

Identifier Source: org_study_id