Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC
- Registration Number
- NCT00633529
- Lead Sponsor
- EMD Serono
- Brief 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.
- Detailed Description
Phase 1b study of escalating doses of weekly subcutaneous IMO-2055 combined with fixed standard dose regimens of oral erlotinib (daily) and IV bevacizumab (every 3 weeks) in patients with previously treated advanced NSCLC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I IMO-2055 Single arm: triple combination
- Primary Outcome Measures
Name Time Method To determine the recommended dosage of IMO-2055 when combined with erlotinib and bevacizumab in patients with AJCC stage 3 or 4 histologically proven non-small cell lung cancer (NSCLC). Assessed on a weekly basis at patient visits.
- Secondary Outcome Measures
Name Time Method To evaluate the safety of weekly IMO-2055 combined with erlotinib plus bevacizumab using NCI CTCAE version 3. Assessed on a weekly basis at patient visits. To investigate potential signs of efficacy using RECIST response rate in measurable patients and PFS in all patients. Assessed every six weeks. To investigate potential drug-drug interactions via a PK study, specifically the effect of IMO-2055 on the PK of bevacizumab and the PK of erlotinib and also the effect of bevacizumab and erlotinib on the PK of IMO-2055. Assessed on a weekly basis at patient visits.
Trial Locations
- Locations (9)
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
New York Oncology Hematology P.C.
🇺🇸Albany, New York, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Cancer Centers of Florida
🇺🇸Ocoee, Florida, United States
Yakima Valley Memorial Hospital/North Shore Cancer Lodge
🇺🇸Yakima, Washington, United States