Accession Number : AD1047204

Title :   Phase 0 Trial of Itraconazole for Early-Stage Non-Small Cell Lung Cancer

Descriptive Note : Technical Report,30 Sep 2015,29 Sep 2016

Corporate Author : Unviersity of Texas Southwestern Medical Center Dallas United States

Personal Author(s) : Gerber,David E

Full Text :

Report Date : 01 Oct 2016

Pagination or Media Count : 11

Abstract : The overall objective of this phase 0 clinical trial is to determine the pharmacodynamic effects of itraconazole. Itraconazolean antifungal agent in clinical use for decades has shown promise as a lung cancer therapy with broad applicability, excellent safety, and a cost one-tenth that of many emerging lung cancer treatments. We have shown that itraconazole has anti-angiogenic properties, inhibits the Hedgehog (Hh) pathway (which plays a fundamental role in cancer stem cell biology), and results in tumor regression in preclinical models. Thus, the specific aims of this project are the following: (Aim 1) Determine effects of itraconazole on tumor angiogenesis; (Aim 2)Determine effects of itraconazole on the Hh pathway; (Aim 3) Determine effects of itraconazole pharmacokinetics (PK) on the pharmacodynamic profile of itraconazole. These aims are achieved through a set of blood-, tissue-, and skin-based biomarkers. Over the past 12 months of this trial, we have continued to enroll patients on the anticipated schedule and performed preliminary imaging, PK, and PD analyses.

Descriptors :   AZOLES , clinical trials , Lung Cancer , neoplasms , pharmacokinetics , biological markers , stem cells

Subject Categories : Medicine and Medical Research

Distribution Statement : APPROVED FOR PUBLIC RELEASE