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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days

Outcome Time Frame:

once every 21 days

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

KSP20008

NCT ID:

NCT00097409

Start Date:

December 2004

Completion Date:

May 2007

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • platinum/taxane-refractory chemotherapy
  • Persistent
  • Recurrent
  • Ovarian Neoplasms

Name

Location
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Oklahoma City, Oklahoma  73112
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Seattle, Washington  98133