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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
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: Ispinesib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 35
Study Start Date: December 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ispinesib
    Other Name: Ispinesib
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097409

Locations
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00097409     History of Changes
Other Study ID Numbers: KSP20008
Study First Received: November 23, 2004
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ovarian cancer
platinum/taxane-refractory chemotherapy
Persistent
Recurrent

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Taxane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013