Back to resultsA Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIIB022 With Paclitaxel and Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive, Anti IGF1R, NSCLC, Open Label, IGF1R, Paraplatin, Cytotoxic, Mitotic Inhibitor, Taxane, Alkylating agent
Eligibility Criteria
Inclusion Criteria:
- Age >/= 18 years old
- Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
- ECOG Performance Status 0 or 1
Exclusion Criteria:
- History of another primary cancer within 3 years
- Any prior or concurrent investigational or standard therapy for treatment of NSCLC
- Prior anti-IGF-1R therapy
- Unstable diabetes
Sites / Locations
- Resesarch Site
- Resesarch Site
- Resesarch Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIIB022 in Combination with Paclitaxel and Carboplatin
Arm Description
BIIB022 in Combination with Paclitaxel and Carboplatin
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00970580
Brief Title
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
Official Title
A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.
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
BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive, Anti IGF1R, NSCLC, Open Label, IGF1R, Paraplatin, Cytotoxic, Mitotic Inhibitor, Taxane, Alkylating agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIIB022 in Combination with Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
BIIB022 in Combination with Paclitaxel and Carboplatin
Intervention Type
Drug
Intervention Name(s)
BIIB022 With Paclitaxel and Carboplatin
Other Intervention Name(s)
Taxol, Paraplatin, BIIB022, Taxane, Anti-IGF-1R, Cytotoxic, Mitotic Inhibitor, IGF-1R, Alkylating agent
Intervention Description
Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >/= 18 years old
Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
ECOG Performance Status 0 or 1
Exclusion Criteria:
History of another primary cancer within 3 years
Any prior or concurrent investigational or standard therapy for treatment of NSCLC
Prior anti-IGF-1R therapy
Unstable diabetes
Facility Information:
Facility Name
Resesarch Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Resesarch Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Resesarch Site
City
Denver
State/Province
Colorado
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
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