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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to dose orally
ECOG Performance status of 0-1
Must not have
Concurrent malignant disease
Malabsorption disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose to end of follow-up, approximately 44 months
Awards & highlights
Summary
This trial tests IDE196 (darovasertib) in patients with primary uveal melanoma needing surgery or radiation. The medication is given to help shrink the tumor and prevent it from coming back.
Who is the study for?
This trial is for individuals with primary localized uveal melanoma who need enucleation or plaque brachytherapy. Participants should be in good physical condition (ECOG 0-1), not have other serious eye diseases, and must not be pregnant or nursing. They should agree to use birth control, be able to take oral medication, and have proper organ function. Those with concurrent cancer, significant heart issues, malabsorption disorders, active HIV/Hep B/C infections or previous PKC inhibitor treatments are excluded.
What is being tested?
The trial is testing Darovasertib (IDE196) as a new treatment option for patients with localized ocular melanoma. It's given before (neoadjuvant) and after (adjuvant) standard procedures like enucleation or plaque brachytherapy to see if it can improve outcomes.
What are the potential side effects?
Potential side effects of Darovasertib may include but are not limited to nausea, fatigue, skin rash, changes in liver enzymes indicating liver stress, vision disturbances due to the drug's effect on the eyes being treated for melanoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take medicine by mouth.
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I am fully active or can carry out light work.
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I do not have any major eye diseases.
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I need eye surgery or radiation for my eye melanoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any other types of cancer.
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I have a condition that affects how my body absorbs nutrients.
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I have heart problems that affect my daily activities.
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I have an active HIV, Hepatitis B, or Hepatitis C infection.
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I have been treated with a PKC inhibitor before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose to end of follow-up, approximately 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose to end of follow-up, approximately 44 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Secondary study objectives
Assessment of visual acuity loss
Evaluate tumor response to neoadjuvant IDE196
Rate of local disease recurrence
+1 moreOther study objectives
Overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: darovasertibExperimental Treatment1 Intervention
IDE196 (darovasertib) oral open label
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Uveal Melanoma include Protein Kinase C (PKC) inhibitors, such as IDE196 (darovasertib), which target the PKC pathway involved in cell proliferation and survival. By inhibiting PKC, these drugs can reduce tumor growth and potentially lead to tumor regression.
This is particularly important for Uveal Melanoma patients as the disease is often aggressive and resistant to conventional therapies. Other treatments may include immune checkpoint inhibitors, which enhance the body's immune response against tumor cells, and targeted therapies that focus on specific genetic mutations within the tumor.
These mechanisms are crucial as they offer more personalized and effective treatment options, improving the prognosis and quality of life for patients with Uveal Melanoma.
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Who is running the clinical trial?
IDEAYA BiosciencesLead Sponsor
4 Previous Clinical Trials
906 Total Patients Enrolled
Matthew Maurer, MDStudy DirectorIDEAYA Biosciences
4 Previous Clinical Trials
754 Total Patients Enrolled
Jasgit Sachdev, MDStudy DirectorIDEAYA Biosciences
3 Previous Clinical Trials
483 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any other types of cancer.You have any other health issues that might make it hard to understand or get accurate results from the study.I can take medicine by mouth.I have a condition that affects how my body absorbs nutrients.I have heart problems that affect my daily activities.I am fully active or can carry out light work.My organs are working well.I do not have any major eye diseases.I have an active HIV, Hepatitis B, or Hepatitis C infection.I need eye surgery or radiation for my eye melanoma.I have been treated with a PKC inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: darovasertib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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