A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970580
• Other study ID #: 212-LC-101
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2009
• Last updated: September 12, 2013
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• BIIB022 With Paclitaxel and Carboplatin
Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

Locations

Country	Name	City	State
United States	Resesarch Site	Denver	Colorado
United States	Resesarch Site	Los Angeles	California
United States	Resesarch Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin		6 months	Yes