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

NCT ID: NCT00097409

Last Updated: 2010-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ispinesib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

New Orleans, Louisiana, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Mayfield Heights, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Abington, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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KSP20008

Identifier Type: -

Identifier Source: org_study_id