EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery
The goal of this clinical research study is to learn about the safety of siRNA-EphA2-DOPC when given to patients with advanced, recurrent cancer. Researchers also want to learn the highest tolerable dose of this drug that can be given.
siRNA-EphA2-DOPC is designed to shut down the activity of a genetic biomarker called EphA2. Biomarkers are found in the blood and tissue and may be related to your reaction to the study drug.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery (IND# 72924): A Phase I Clinical Trial|
- Toxicity Profile of siRNA-EphA2 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Dose-limiting toxicity (DLT) defined as any event during the first cycle of study treatment that is considered possibly, probably or definitely related to study drug: Hematologic toxicity or Non-hematologic toxicity.
|Study Start Date:||July 2015|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
siRNA-EphA2-DOPC administered by vein twice weekly on Days 1 and 4 of each week for 3 weeks. One cycle equals 3 weeks of treatment (21 day schedule). Treatment will normally be administered on an outpatient basis; however, inpatient administration may be relevant in some situations. siRNA-EphA2-DOPC administered over 30 (+/- 5 minutes). Starting dose level of siRNA-EphA2-DOPC 450 ug/m2 by vein twice weekly.
Starting dose: 450 ug/m2 by vein twice weekly on Days 1 and 4 of each 3 week cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01591356
|Contact: Robert Coleman, MD||713-745-3357|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert Coleman, MD||M.D. Anderson Cancer Center|