NCT04088318

A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: OnQuality Pharmaceuticals (USA) LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hand-Foot Skin Reaction (HFSR)

Interventions

Type	Name	Description
DRUG	OQL011	OQL011 is an ointment containing active ingredient.
DRUG	Vehicle Ointment	Vehicle ointment is an ointment containing no active ingredient.

Timeline

• Start date: 2019-12-09
• Primary completion: 2024-02-26
• Completion: 2024-06-01
• First posted: 2019-09-12
• Last updated: 2024-03-04

Locations

33 sites across 3 countries: United States, China, India

Regulatory

• FDA-regulated drug study