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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
Outcome Time Frame:
6 months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
212-LC-101
NCT ID:
NCT00970580
Start Date:
October 2009
Completion Date:
September 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Resesarch Site | Denver, Colorado |
| Resesarch Site | Los Angeles, California |
