Purpose of this Study
We are doing this study to find out if an experimental drug called IDE196 (the study drug) is a safe and effective treatment for uveal melanoma (melanoma in the eye) that has spread to another part of the body or other types of cancer with a tumor mutation in genes called GNAQ, GNA11, or PRKC.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with uveal melanoma that has spread to other parts of their body (metastasis); OR
- Are diagnosed with another form of cancer that has a tumor mutation associated with the genes GNAQ, GNA11, or PRKC
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join the study, you will come in for a screening visit to see if you are eligible. During this visit, you will:
- Have a physical exam
- Have blood draws and give urine samples
- Have an eye exam
- Get a chest X-ray
- Have lung function tests
- If applicable, have a tumor biopsy to test for mutations in its genes
- Take the study drug along with another drug called crizotinib by mouth every day for drug cycles that last 4 weeks each
- Have images (CT or MRI) taken of your tumors every 2 months for up to a year
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/2 Study of IDE196 In Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Principal Investigator
April
Salama
Protocol Number
PRO00109482
NCT ID
NCT03947385
Phase
I/II
Enrollment Status
Open to Enrollment