OQL011 / OnQuality Pharma - LARVOL DELTA

NOVA-II: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (clinicaltrials.gov) - P2 | N=170 | Active, not recruiting | Sponsor: OnQuality Pharmaceuticals (USA) LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology

NOVA-II: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: OnQuality Pharmaceuticals (USA) LLC | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Oncology

NOVA-II: Part 2 study to evaluate the safety and efficacy of OQL011 on VEGF inhibitor-associated hand-foot skin reaction in patients with cancer. (ASCO-GU 2023) - P2 | "Background: Hand-foot skin reaction (HFSR) is associated with the use of multi-targeted tyrosine kinase inhibitors sharing vascular endothelial growth factor receptor inhibitor (VEGFRi) activity (e.g., cabozantinib, regorafenib, sorafenib, sunitinib)...Study enrollment for Part 2 is currently ongoing in the United States, India, and China. (NCT04088318) Clinical trial information: NCT04088318."

Clinical • Genito-urinary Cancer • Oncology

NOVA-II: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: OnQuality Pharmaceuticals (USA) LLC | N=112 ➔ 170 | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Oct 2022 ➔ Jun 2023

Enrollment change • Trial completion date • Trial primary completion date • Oncology

OnQuality Pharmaceuticals to Present NOVA-II Phase 2 Trial Update and Oncologist Survey Demonstrating Oncodermatology Unmet Need at ASCO GU (BioSpace) - '"When it comes to treating cancer, it is important to maintain dose intensity of cancer treatment. Unfortunately, oncodermatology conditions like Hand-Foot Skin Reaction often force us to make those difficult decisions, and the survey being presented at ASCO GU demonstrates the significant unmet need in this space,' said Dr. Nicholas Vogelzang...'I am glad to see the NOVA-II trial is moving forward to Part 2 to evaluate OQL011 at a higher dose level.'"

Media quote

[VIRTUAL] A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR- ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS (MASCC-ISOO 2021) - P2 | "The correlation between IGA, NCI CTCAE v5.0 for PPE, and patient-reported outcomes including Visual Analog Scale of Pain, Hand-foot Quality of Life questionnaire will also be evaluated. This study is actively enrolling."

Clinical • P2 data • Dermatology • Oncology • Pain

[VIRTUAL] A phase II study to evaluate the safety and efficacy of OQL011 on VEGFR inhibitor-associated hand-foot-skin reaction in cancer patients. (ASCO 2021) - P2 | "Clinical Trial Registry Number: NCT04088318 Funding: OnQuality Pharmaceuticals (USA) LLC Background: Hand-Foot Skin Reaction (HFSR) is frequently associated with the use of multi-targeted tyrosine kinase inhibitors of the vascular endothelial growth factor receptor (VEGFRi) such as cabozantinib, regorafenib, sunitinib, and lenvatinib...The correlation between IGA, NCI CTCAE v5.0 for PPE, and patient reported outcomes including Visual Analog Scale of Pain, Hand-foot Quality of Life questionnaire will also be evaluated . This study began enrolling patients in December 2019 and is ongoing."

Clinical • P2 data • Dermatology • Oncology • Pain

NOVA-II: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (clinicaltrials.gov) - P2; N=112; Recruiting; Sponsor: OnQuality Pharmaceuticals (USA) LLC; Trial completion date: Jun 2022 ➔ Apr 2023; Trial primary completion date: Mar 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • Oncology

NOVA-II: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (clinicaltrials.gov) - P2; N=112; Recruiting; Sponsor: OnQuality Pharmaceuticals (USA) LLC; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Apr 2021 ➔ Mar 2022

Trial completion date • Trial primary completion date • Oncology

[VIRTUAL] OnQuality Pharmaceuticals (BIO 2021) - "Our leading compound OQL011 is being studied in a phase 2 clinical trial that is currently enrolling. We are developing two assets that are currently in the pre-clinical stage and are scheduled to enter clinical trials in the near future. Additionally, we have two promising assets that are in the early discovery stage targeting oncogastroenterology conditions."

Gastroenterology • Oncology

OnQuality Pharmaceuticals to Present on NOVA-II Trial Evaluating OQL011 at the 2021 ASCO and MASCC/ISOO Annual Meetings (PRNewswire) - “OnQuality Pharmaceuticals…announced that abstracts for the NOVA-II clinical trial evaluating OnQuality's lead candidate, OQL011, have been selected for presentations at two upcoming meetings: a Trial in Progress poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from June 4-8, 2021, and an oral presentation at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) Annual Meeting, being held virtually from June 24-26, 2021. The abstracts for both presentations include an update on the ongoing Phase II clinical trial and are both titled ‘A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (NOVA-II)."

P2 data • Oncology