Ointment Being Studied for Hand-Foot Skin Reaction Related to Kidney Cancer Treatment

While multi-targeted tyrosine kinase inhibitors (TKIs) such as Cabometyx (cabozantinib), Stivarga (regorafenib) and Sutent (sunitinib) have improved outcomes for patients with kidney cancer in recent years, they also come with their own set of side effects, such as hand-foot skin reaction — a condition that involves redness, swelling, blisters and pain in the hands and/or soles of the feet.

The NOVA-II clinical trial is currently investigating the effectiveness of a topical ointment, OQL011, to treat hand-foot skin reaction in patients undergoing treatment with TKIs. The trial, which is currently enrolling patients, was discussed at the 2023 ASCO Genitourinary Symposium.

“Hand-foot skin reaction, or HFSR, occurs with targeted multikinase inhibitors that incorporate blockade of a vascular endothelial growth factor receptor, or VEGFR,” Robert Claude Tyler, of OnQuality Pharmaceuticals, the developer of OQL011 said in a presentation of the trial.

There is currently no Food and Drug Administration (FDA)-approved therapy for hand-foot skin reaction, a condition which is estimated to affect between 31% and 79% of patients on multi-targeted TKIs.

Researchers on part 2 of the NOVA-II trial plan to enroll approximately 140 patients on multi-targeted TKIs who are experiencing hand-foot skin reaction. Patients will be randomly assigned to receive one of three doses of OQL011 or a non-medicated ointment.

OQL011 will be applied to the hands and feet and then researchers will evaluate the reaction at the start of treatment, compared to visit 2 (14 days into participation) and visit 3 (28 days into participation).

The main goals of the trial involve evaluating how OQL011 affects the severity of hand-foot skin reaction. Patient pain, quality of life and side effects from the ointment will also be evaluated.

“HSFR can be painful and impacts daily activities of living, so changes in the hand-foot quality of life scores or numerical pain rating scale will be captured as secondary events,” Tyler said.

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