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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
Not Enrolling
Both
Non-Small Cell Lung Cancer

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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 SiteDenver, Colorado  
Resesarch SiteLos Angeles, California