Non-Small Cell Lung Cancer Studies
   
  212-LC-101
Non-Small Cell Lung Cancer
 
 
   
 
 
 
 
 
 
 
 
 
 

 


212-LC-101, Non-Small Cell Lung Cancer

Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

This study is currently recruiting participants.

Purpose

To determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naïve, Stage IIIB/IV Non-Small Cell Lung Cancer


Study Type:  Interventional
Study Design:  Treatment, Open-Label, Single Group Assignment, Safety Study
Official Title: A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naïve, Stage IIIB/IV Non-Small Cell Lung Cancer


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin [Time Frame: 6 months] [Designated as safety issue: Yes]

 
Estimated Enrollment:   18
Study Start Date:   October 2009
Estimated Study Completion Date:   May 2011
Estimated Primary Completion Date:  

November 2010 (Final data collection date to primary outcome measure)

 

Arms Assigned Interventions
BIIB022 in Combination with Paclitaxel and Carboplatin
Experimental
  BIIB022 in Combination with Paclitaxel and Carboplatin
Drug: BIIB022 With Paclitaxel and Carboplatin
  Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin


Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Treatment-naïve Stage IIIB/IV Non-Small Cell Lung Cancer
  3. ECOG Performance Status 0 or 1

Exclusion Criteria:

  1. History of another primary cancer within 3 years
  2. Any prior or concurrent investigational or standard therapy for treatment of NSCLC
  3. Prior anti-IGF-1R therapy
  4. Unstable disease

Please refer to: www.biogenideconcology.com

Please refer to the clinicaltrials.gov website for further details on the study: http://www.clinicaltrials.gov/ct2/show/NCT00970580

To contact Biogen, click here.

 
 
  
 
THIS WEBSITE IS INTENDED FOR US RESIDENTS ONLY
 
 

© 2009 Biogen Idec