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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00651508
First received: March 26, 2008
Last updated: January 24, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: KOS-1584
Phase 2

Bristol-Myers Squibb has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate of KOS-1584 [ Time Frame: up to one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 25mg/m2 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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651508

Locations
United States, Kentucky
Consultants In Blood Disorders & Cancer
Louisville, Kentucky, United States, 40207
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00651508     History of Changes
Other Study ID Numbers: CA202-002, KOS-1584-203
Study First Received: March 26, 2008
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration
Russia: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health & Social Welfare

Keywords provided by Bristol-Myers Squibb:
Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014