Effectiveness of KOS-862 in the Treatment of Lung Cancer

This study has been terminated.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00080509

First received: April 5, 2004

Last updated: February 2, 2010

Last verified: November 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 5, 2004
Last Updated Date	February 2, 2010
Start Date ^ICMJE	December 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	NSCLC
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00080509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effectiveness of KOS-862 in the Treatment of Lung Cancer
Official Title ^ICMJE	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
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lung Cancer
Intervention ^ICMJE	Drug: KOS-862
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	85
Completion Date	November 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00080509
Other Study ID Numbers ^ICMJE	KOS-201/NO17352
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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