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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00651508
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm 25mg/m2
KOS-1584 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.
Other Name: BMS-878271


Outcome Measures

Primary Outcome Measures :
  1. Objective response rate of KOS-1584 [ Time Frame: up to one year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00651508     History of Changes
Other Study ID Numbers: CA202-002
KOS-1584-203
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents