Open
Actively Recruiting
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
About
Brief Summary
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
- Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
- Able to dose orally
- ECOG Performance status of 0-1
- No other significant underlying ocular disease
- Adequate organ function
- Not pregnant/nursing or planning to become pregnant. Willing to use birth control
Exclusion Criteria:
- Previous treatment with a Protein Kinase C (PKC) inhibitor
- Concurrent malignant disease
- Active HIV infection or Hep B/C
- Malabsorption disorder
- Unable to discontinue prohibited medication
- Impaired cardiac function or clinically significant cardiac disease
- Any other condition which may interfere with study interpretation or results
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Study Stats
Protocol No.
23-001460
Category
Head and Neck Cancer
Principal Investigator
Contact
Location
- UCLA Westwood