EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery
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|ClinicalTrials.gov Identifier: NCT01591356|
Recruitment Status : Recruiting
First Posted : May 4, 2012
Last Update Posted : March 14, 2018
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).
This is an investigational study. siRNA-EphA2-DOPC is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 40 patients will be enrolled on this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: siRNA-EphA2-DOPC||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery (IND# 72924): A Phase I Clinical Trial|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
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.
- Toxicity Profile of siRNA-EphA2 [ Time Frame: 21 days ]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.
- Percent of Patients with EphA2 Expression Modulation [ Time Frame: Cycle 1 Day 1: Pre-treatment, 15 ± 2 min from start of infusion, End of Infusion ± 2 min, and 15 ± 2 min, 30 ± 2 min, 60 ± 10 min, 90 ± 10 min, 180 ± 10 min, 360 ± 10 min, 24 hours following End of Infusion ]Percent of patients with EphA2 expression modulation, defined as a 50% decrease from baseline expression, calculated along with 90% exact confidence intervals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|