Status:
COMPLETED
Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Must have a screening CA-125 of greater than or equal to 40 U/ml.
- Must have received only one prior platinum/taxane-based chemotherapy regimen.
- Blood tests will be done to check if blood counts are adequate for taking part in the study.
- Exclusion criteria:
- Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- Females who are pregnant or nursing.
- Any unstable, pre-existing major medical condition or history of other cancers.
- Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00097409
Start Date
December 1 2004
End Date
May 1 2007
Last Update
October 4 2010
Active Locations (9)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
3
GSK Investigational Site
St Louis, Missouri, United States, 63110
4
GSK Investigational Site
Mayfield Heights, Ohio, United States, 44124