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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097409
Recruitment Status : Completed
First Posted : November 24, 2004
Last Update Posted : October 4, 2010
Information provided by:

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 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Ispinesib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study of Ispinesib in Subjects With Platinum/Taxane-Refractory or Resistant Relapsed Ovarian Cancer
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days [ Time Frame: once every 21 days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097409

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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, Ohio
GSK Investigational Site
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
GSK Investigational Site
Abington, Pennsylvania, United States, 19001-3788
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98101
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
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Responsible Party: Study Director, GSK Identifier: NCT00097409    
Other Study ID Numbers: KSP20008
First Posted: November 24, 2004    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010
Keywords provided by GlaxoSmithKline:
ovarian cancer
platinum/taxane-refractory chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type