CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 13 enrolled
Drug / intervention
Itraconazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02357836
NCT02357836Early Ph 1Completed
CompareCT.gov

Phase 0 Pharmacodynamic Study of the Effects of Itraconazole on Tumor Angiogenesis and the Hedgehog Pathway in Early-stage Non-small Cell Lung Cancer

University of Texas Southwestern Medical Center·interventional·Posted Feb 6, 2015·Updated May 3, 2021

In Brief

A Early Phase 1 clinical trial evaluating Itraconazole for Non-small Cell Lung Cancer. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the pharmacodynamics effects of itraconazole in early-stage non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 6, 2015
Enrollment StartJun 1, 2015
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.4 years ago

Interventions

Itraconazoledrug

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.