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Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00097409
First received: November 23, 2004
Last updated: October 1, 2010
Last verified: October 2010
History of Changes

November 23, 2004
October 1, 2010
December 2004
May 2007   (final data collection date for primary outcome measure)
Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days [ Time Frame: once every 21 days ]
Not Provided
Complete list of historical versions of study NCT00097409 on ClinicalTrials.gov Archive Site
Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days [ Time Frame: once every 21 days ]
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Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer
A Phase II, Open-Label Study of Ispinesib in Subjects With Platinum/Taxane-Refractory or Resistant Relapsed Ovarian Cancer

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 chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24 hour period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Ispinesib
Other Name: Ispinesib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097409
KSP20008
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP