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

Study Overview
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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.

Official Title
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Randomized, Multicenter, Prospective Two-arm, Open-label Phase II Study to Investigate the Efficacy and Safety of Two ZK219477 i.v. Infusions (3-hour Infusion of 16mg/m2 Versus 0.5-hour Infusion of 16 mg/m2) in Patients With Recurrent Ovarian Cancer Progressing During, or Within 6 Months of the End of Platinum-based Chemotherapy

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: Sagopilone (BAY86-5302 , ZK219477)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sagopilone, 0.5 h infusion<br>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 | Drug: Sagopilone (BAY86-5302 , ZK219477)<br>* 10.5 mg lyophilized sagopilone per vial<br>|
| Experimental: Sagopilone, 3 h infusion<br>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 | Drug: Sagopilone (BAY86-5302 , ZK219477)<br>* 10.5 mg lyophilized sagopilone per vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | up to 1 year after LPLTV | 
| Time to disease progression |  | up to 1 year after LPLTV | 
| Number of participants with adverse events |  | Approximately 30 weeks |