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
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
  • 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
Contact
MARIA ZAMUDIO
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05907954
For detailed technical eligibility, visit ClinicalTrials.gov.