Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT00651508
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm 25mg/m2 KOS-1584 KOS-1584 25mg/m2
- Primary Outcome Measures
Name Time Method Objective response rate of KOS-1584 up to one year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Consultants In Blood Disorders & Cancer
🇺🇸Louisville, Kentucky, United States