25
Participants
Start Date
February 28, 2014
Primary Completion Date
October 27, 2016
Study Completion Date
September 28, 2020
DOTAP:Chol-TUSC2
Starting Dose 0.045 mg/kg by vein on day 1 of each 21 day cycle; Phase II is Maximum Tolerated Dose from Phase I.
Erlotinib
Starting Dose 100 mg by mouth each day of a 21 day cycle (except for first week of Cycle 1, if enrolled in Phase II delayed-schedule group). Phase II is Maximum Tolerated Dose from Phase I.
Dexamethasone
8 mg orally 24 and 12 hours and 20 mg by vein 30 minutes before DOTAP:Chol-TUSC2 treatment followed by 8 mg orally at 12, 24 and 36 hours after treatment (total number doses = 5).
Diphenhydramine
50 mg by mouth or by vein 30 minutes prior to treatment with DOTAP:Chol TUSC2
UT MD Anderson Cancer Center, Houston
Lead Sponsor
Genprex, Inc.
INDUSTRY