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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ispinesib

Drug

Primary outcomes

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

Time frame: once every 21 days

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Nov 24, 2004
Registry last updated: Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed