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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Desoxyepothilone B

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00080509 History of Changes
Other Study ID Numbers:	KOS-201/NO17352
Study First Received:	April 5, 2004
Last Updated:	February 2, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 13, 2012