TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

October 27, 2016

Study Completion Date

September 28, 2020

Conditions
Lung Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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).

DRUG

Diphenhydramine

50 mg by mouth or by vein 30 minutes prior to treatment with DOTAP:Chol TUSC2

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genprex, Inc.

INDUSTRY

NCT01455389 - TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer | Biotech Hunter | Biotech Hunter