Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin for Non-Small Cell Lung Cancer With KRAS or EGFR Activation
NCT00861627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2015-12-02
Summary
The purpose of this Phase 2 study is to investigate whether intravenous administration of a wild type reovirus (REOLYSIN®) in combination with paclitaxel and carboplatin is effective and safe in the treatment of Non-Small Cell Lung Cancer with KRAS or EGFR activation.
Conditions
- Carcinoma, Non-small Cell Lung
Interventions
- BIOLOGICAL
-
REOLYSIN®
3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
- DRUG
-
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
- DRUG
-
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of 21 day cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Miguel Villalona, MD · Ohio State University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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