Back to resultsStudy to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KOS-1584
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
Eligibility 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.
Sites / Locations
- Consultants In Blood Disorders & Cancer
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm 25mg/m2
Arm Description
KOS-1584 25mg/m2
Outcomes
Primary Outcome Measures
Objective response rate of KOS-1584
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651508
Brief Title
Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm 25mg/m2
Arm Type
Experimental
Arm Description
KOS-1584 25mg/m2
Intervention Type
Drug
Intervention Name(s)
KOS-1584
Other Intervention Name(s)
BMS-878271
Intervention Description
25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Objective response rate of KOS-1584
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Consultants In Blood Disorders & Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
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