Part 2 of the NOVA-II phase 2 trial evaluating OQL011 has enrolled the first patient with cancer with VEGFR inhibitor-associated hand-foot skin reaction.
Trial Name: A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
ClinicalTrials.gov Identifier: NCT04088318
Sponsor: OnQuality Pharmaceuticals
Recruitment Contact: Mark Webb, PhD, +1-801-618-8292, Mark.Webb@OnQualityRx.com and Johnny Ju, MSc, +86-137-6163-6367, Juegang.Ju@OnQualityRx.com
Completion Date: October 2023
The first patient in has been enrolled in part 2 of the phase 2 NOVA-II clinical trial (NCT04088318) evaluating OQL011, a topical ointment for the management of vascular endothelial growth factor receptor (VEGFR) inhibitor-associated hand-foot skin reaction (HFSR) in patients with cancer, according to OnQuality Pharmaceuticals.1
OQL011 is a proprietary ointment which targets the key pathway of VEGFR inhibitor-associated HFSR. The agent has potential to improve or restore VEGF signaling and alleviate HFSR symptoms.
"Our team is delighted to start part 2 of the NOVA-II clinical trial to address the unmet need of cancer-therapy-induced skin toxicities," said Hong Tang, MD, chief medical officer and co-founder of OnQuality Pharmaceuticals, in the press release. "OQL011 generated positive initial findings in part 1 of the phase 2 study and we look forward to advancing the part 2 study to determine the optimal dosage of OQL011 for phase 3."
HFSR is a common adverse event (AE) induced by VEGFR inhibitor treatment in patients with cancer. In hopes of providing more options for these patients, the global, multicenter, randomized, double-blinded, dose-ranging phase 2 NOVA-II trial is evaluating the safety and efficacy of OQL011 compared with vehicle ointment as a topical ointment in patients with VEGFR inhibitor-associated HFSR.2
This study also will identify the optimal dosage for a phase 3 study of the agent and explore the pharmacokinetics profile of OQL011 in patients with HFSR.
There are 4 dose levels patients can be treated with in part 2 of the trial. Doses 1, 2, and 3 will be applied topically, 3 times a day, for up to 4 weeks, while patients in the control arm will be given vehicle ointment to be applied topically 3 times a day, for up to 4 weeks.
Approximately 170 patients will be included in the study. Enrollment in the trial is open to patients 18 years and older who are receiving VEGFR inhibitor-based anticancer therapy, have HFSR severity of grade 3 or higher, and an ECOG performance status of 0-2.
The primary end point of part 2 of the study is the proportion of patients achieving investigator's global assessment (IGA)-HFSR grade 0 or 1. Secondary end points include proportion of patients achieving at least 2-grade improvement in IGA-HFSR, change from baseline in patient reported pain, quality of life, safety, and the exposure-response relationship of different dose levels of OQL011.
According to initial findings from part 1 of the phase 2 trial, OQL011 is safe and well tolerated in patients with cancer who developed HFSR. There were no significant AEs observed in part 1.
The trial is actively recruiting patients in California, Connecticut, Illinois, Maryland, Massachusetts, Missouri, Ohio, and Texas, and has an estimated study completion date of October 2023.
