NCT00097409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2004

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

2.4 years

First QC Date

November 23, 2004

Last Update Submit

October 1, 2010

Conditions

Ovarian Cancer

Keywords

ovarian cancerplatinum/taxane-refractory chemotherapyPersistentRecurrent

Outcome Measures

Primary Outcomes (1)

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

    once every 21 days

Secondary Outcomes (1)

  • 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

Interventions

IspinesibDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

Mayfield Heights, Ohio, 44124, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

GSK Investigational Site

Abington, Pennsylvania, 19001-3788, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Seattle, Washington, 98101, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 23, 2004

First Posted

November 24, 2004

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(9)