Trial Condition(s):

Ovarian Neoplasms

Efficacy and safety study of ZK219477 in patients with recurrent ovarian cancer

Bayer Identifier:

91447

ClinicalTrials.gov Identifier:

NCT00246688

EudraCT Number:

2005-000635-15

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
63
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
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Investigative Site

Surrey, United Kingdom, SM2 5PT

Status
Completed
 
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Investigative Site

Newcastle upon Tyne, United Kingdom, NE4 6BE

Status
Completed
 
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Investigative Site

Guildford, United Kingdom, GU2 7XX

Status
Completed
 
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Investigative Site

Birmingham, United Kingdom, B18 7QH

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M20 4BX

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G11 6NT

Status
Completed
 
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Investigative Site

Cardiff, United Kingdom, CF14 7TB

Status
Completed
 
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Investigative Site

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
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Investigative Site

London, United Kingdom, NW1 2TG

Status
Completed
 
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Investigative Site

Belfast, United Kingdom, BT9 7AB

Status
Terminated
 
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Investigative Site

Derby, United Kingdom, DE1 2QY

Status
Completed
 
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Investigative Site

Leicester, United Kingdom, LE1 5WW

Status
Terminated
 
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Investigative Site

Hull, United Kingdom, HU8 9HE

Status
Completed
 
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Investigative Site

ANGERS, France, 49933

Status
Terminated
 
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Investigative Site

Caen, France, 14076

Status
Terminated
 
Locations

Investigative Site

Strasbourg, France, 67085

Status
Terminated
 
Locations

Investigative Site

Lille, France, 59020

Status
Terminated
 

Trial Design