Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC
NCT00633529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2013-10-22
Summary
To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC.
Conditions
Interventions
- DRUG
-
IMO-2055
0.08, 0.16, or 0.32 mg/kg SC (subcutaneous) on days 1,8,and 15 of every 21 day cycle until evidence of progressive disease, unacceptable treatment-related toxicities, withdrawal of patient consent and/or Investigator decision to withdraw study therapy with documented reason, whichever occurs first.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Phil Breitfeld, MD · EMD Serono
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2010-10-31
- Completion
- 2011-03-31
Countries
- United States
Study Locations
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