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

October 1, 2010 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Ovarian Cancer

Intervention / Treatment

Drug: Ispinesib

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - GSK Investigational Site
- Louisiana
  - New Orleans, Louisiana, United States, 70115
    - GSK Investigational Site
- Missouri
  - St. Louis, Missouri, United States, 63110
    - GSK Investigational Site
- Ohio
  - Mayfield Heights, Ohio, United States, 44124
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001-3788
    - GSK Investigational Site
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
- Washington
  - Seattle, Washington, United States, 98101
    - GSK Investigational Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days Time Frame: once every 21 days	once every 21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	once every 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)