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.
You are being asked to take part in this study because you have advanced cancer that is recurrent (has come back).
|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|