A Phase II Study of OQL011 in People with Hand-Foot Skin Reaction as a Result of Targeted Cancer Treatments

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Full Title

A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational treatment OQL011 in people who develop hand-foot skin reaction as a result of taking a type of targeted drug known as a VEGFR inhibitor. Examples of VEGFR inhibitor drugs include sorafenib, regorafenib, axitinib, pazopanib, lenvatinib, cabozantinib, and sunitinib.

Also known as “palmar-plantar erythrodysesthesia,” hand-foot skin reaction is a condition that affects the skin in the palms of the hands and soles of the feet. Symptoms include abnormal redness, swelling, peeling and flaking, blistering, and pain on the palms and soles. Hand-foot skin reaction can impair a person’s ability to do routine daily activities, such as walking, or using the hands.

OQL011 is a type of drug that dilates blood vessels, and it is designed to protect cells from the damage caused by targeted therapies. Patients in this study will receive OQL011 ointment or a placebo (inactive) ointment and will be asked to apply it to their hands and feet three times a day for six weeks.

Eligibility

This study is for patients age 18 and older who are experiencing hand-foot skin reaction as a result of targeted (VEGFR inhibitor) cancer treatment.

For more information about this study, please contact Dr. Mario Lacouture at 646-608-2337 or lacoutum@mskcc.org.

Protocol

20-134

Phase

II

Investigator

Co-Investigators