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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate of KOS-1584

Outcome Time Frame:

up to one year

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA202-002

NCT ID:

NCT00651508

Start Date:

April 2008

Completion Date:

October 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Consultants In Blood Disorders & CancerLouisville, Kentucky  40207