NCT05187884

Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: St Vincent's Hospital, Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility and tolerability of neo-adjuvant/adjuvant Darovasertib on uveal melanoma patients. Who is it for? Patients may be eligible to join this study with high-risk uveal melanoma and planned to undergo enucleation Study details: Eligible patients will undergo up to 4 weeks of treatment with Darovasertib (300mg, twice a day as a starting dose) and once determiend safe then up to 6 months after fulfilling inclusion/exclusion criteria and consent. Select patients will undergo adjuvant treatment for 6 months based on their initial response. It is hoped that this research will provide insight into the safety and tolerability of Darovasertib. Furthermore, it aims to document the pharmacodynamic and pharmacokinectic effects of Darovasertib on uveal melanoma patients.

Conditions

• Ocular Melanoma

Interventions

Type	Name	Description
DRUG	Darovasertib	Oral Darovasertib 300 mg tablets twice daily

Timeline

• Start date: 2022-05-03
• Primary completion: 2025-01-01
• Completion: 2025-11-01
• First posted: 2022-01-12
• Last updated: 2025-06-24

Locations

2 sites across 1 country: Australia