Effectiveness of KOS-862 in the Treatment of Lung Cancer
February 2, 2010 updated by: Bristol-Myers Squibb
A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
The purpose of this study is to determine whether a potential drug known as KOS-862 or "Epothilone D" has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.
Study Overview
Detailed Description
To determine the antitumor activity, based on the confirmed objective response rate, of KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following initial chemotherapy for advanced or metastatic disease.
Study Type
Interventional
Enrollment
85
Phase
- Phase 2
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years of age
- Measurable disease
- One previous treatment of a platinum based drug such as cisplatin or carboplatin
- At least 3 weeks since last surgery/radiation/chemotherapy
Exclusion Criteria:
- Brain metastases
- Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing
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 |
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NSCLC
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2003
Study Completion
November 1, 2004
Study Registration Dates
First Submitted
April 5, 2004
First Submitted That Met QC Criteria
April 6, 2004
First Posted (Estimate)
April 7, 2004
Study Record Updates
Last Update Posted (Estimate)
February 3, 2010
Last Update Submitted That Met QC Criteria
February 2, 2010
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOS-201/NO17352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.