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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

RECRUITINGPhase 2Sponsored by IDEAYA Biosciences
Actively Recruiting
PhasePhase 2
SponsorIDEAYA Biosciences
Started2023-07-03
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →

NCT05907954

Summary

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerUveal Melanoma

Locations13 sites

HonorHealth Research Institute
Scottsdale, Arizona, 85258
(480) 323-1791clinicaltrials@honorhealth.com
Moores Cancer Center
La Jolla, California, 92093
Catherine O'Neil(858) 822-6575croneil@health.ucsd.edu
UCLA Medical Center
Los Angeles, California, 90024
Adyel Annelus310-794-4955aannelus@mednet.ucla.edu
Stanford Cancer Institute
Palo Alto, California, 94305
Claire A Billman, B.S650-736-6425cbillman@stanford.edu
Sarah Cannon Research Institute
Denver, Colorado, 80218
Sarah Cannon720-754-2610cann.ddudenvergeneral@sarahcannon.com

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