NCT00085813

Brief Summary

This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr 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

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2003

Geographic Reach
3 countries

11 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

Study Start

First participant enrolled

December 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

1.8 years

First QC Date

June 14, 2004

Last Update Submit

October 1, 2010

Conditions

Non-Small-Cell Lung Cancer

Keywords

Platinum-RefractoryPlatinum-RelapsedNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Assessment of Overall Response Rate of tumor.

Secondary Outcomes (1)

  • Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.

Interventions

IspinesibDRUG

Eligibility Criteria

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

You may qualify if:

  • Must have received only one prior platinum-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.
  • 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 (11)

GSK Investigational Site

Scottsdale, Arizona, 85259, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32224, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Rochester, New York, 14623, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27403, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38104, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

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

June 14, 2004

First Posted

June 17, 2004

Study Start

December 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(7)GB(1)BE(3)