Neoadjuvant Itraconazole in Non-small Cell Lung Cancer

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2018

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Itraconazole

"Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK (pharmacokinetics) analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."

Trial Locations (1)

75390

UT Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

University of Texas Southwestern Medical Center

OTHER

NCT02357836 - Neoadjuvant Itraconazole in Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter