Phase 0 Trial of Itraconazole for Early-Stage Non-Small Cell Lung Cancer
Technical Report,30 Sep 2015,29 Sep 2016
Unviersity of Texas Southwestern Medical Center Dallas United States
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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 2Determine 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.
- Medicine and Medical Research