Effectiveness of KOS-862 in the Treatment of Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: KOS-862	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Desoxyepothilone B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

NSCLC

Estimated Enrollment:	85
Study Start Date:	December 2003
Estimated Study Completion Date:	November 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Click here for more information about our studies This link exits the ClinicalTrials.gov site

Study ID Numbers:	KOS-201/NO17352
First Received:	April 5, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00080509
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasm Metastasis

Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00080509