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ACTIVE NOT RECRUITING
NCT05187884
PHASE2

Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma

Sponsor: St Vincent's Hospital, Sydney

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2022-05-03

Completion Date

2025-11-01

Last Updated

2025-06-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Darovasertib

Oral Darovasertib 300 mg tablets twice daily

Locations (2)

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, Australia

Alfred Hospital

Melbourne, Victoria, Australia