A Study to Evaluate a Medication Used in Treating Hand-Foot Skin Reaction (HFSR) in Cancer Patients (NOVA-II)

Official Title: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (NOVA-II)

Purpose:

Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) treatment in cancer patients. The main purpose of this study is to evaluate the safety and efficacy of OQL011 compared to vehicle ointment in treating patients with moderate to severe VEGFRi-associated HFSR. This study will also identify an optimal dosage for Phase III study and explore the pharmacokinetics profile of OQL011 in HFSR patients.

Eligibility criteria:

- Patient must be age 18 years of age or older.
- Patient must have a confirmed cancer diagnosis for which VEGFRi treatment is indicated, and must be currently under VEGFRi-based anti-cancer therapy with stable dosage for ≥ 1 week.
- Patient on pain medications is allowed provided they have been on stable dosage in the past 1 week and is going to continue at the same dosage.

Contact Information


Erin Frey

Erin.Frey@osumc.edu

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