Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Open Label, Multi-center, Phase 2 Study of KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Previously Treated With First-Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651508
• Other study ID #: CA202-002
• Secondary ID: KOS-1584-203
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: January 24, 2011
• Start date: April 2008
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of Health & Social Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV.

• Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC.

• Good performance status.

Exclusion Criteria:

• Prior treatment with an epothilone.

• Known central nervous system (CNS) metastases.

• Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• KOS-1584
25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
United States	Consultants In Blood Disorders & Cancer	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate of KOS-1584		up to one year	No
Secondary	Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.		up to 2 years	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form