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Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma

NCT05187884 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-23

No results posted yet for this study

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

DRUG

Darovasertib

Oral Darovasertib 300 mg tablets twice daily

Sponsors & Collaborators

  • St Vincent's Hospital, Sydney

    lead OTHER

Principal Investigators

  • Anthony Joshua, FRACP, MBBS, PhD · St Vincent's Hospital, Sydney

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2025-01-01
Completion
2025-11-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187884 on ClinicalTrials.gov