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

Ovarian Cancer Clinical Trial

Official title:

A Phase II, Open-Label Study of Ispinesib in Subjects With Platinum/Taxane-Refractory or Resistant Relapsed Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097409
• Other study ID #: KSP20008
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2004
• Last updated: October 1, 2010
• Start date: December 2004
• Est. completion date: May 2007

Study information

• Verified date: October 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Ispinesib

Locations

Country	Name	City	State
United States	GSK Investigational Site	Abington	Pennsylvania
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mayfield Heights	Ohio
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days		once every 21 days
Secondary	Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days		once every 21 days