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New treatment option for Metastatic Uveal Melanoma
Official title Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
ClinicalTrials.gov ID: NCT03947385
What this study is testing
What is IDE196?
IDE196 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic uveal melanoma.
Also referred to as Protein Kinase C (PKC) Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be ≥18 years of age and able to provide written informed consent
- Diagnosis of the following: o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment...
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \> 3 months
- Adequate organ function at screening
You likely can't join if
- Previous treatment with a PKC inhibitor
- Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
- Known symptomatic brain metastases
- Adverse events from prior anti-cancer therapy that have not resolved
- Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
- Active infection requiring ongoing therapy
See the full eligibility criteria
- Patient must be ≥18 years of age and able to provide written informed consent
- Diagnosis of the following: o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most...
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \> 3 months
- Adequate organ function at screening
- Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential Crizotinib Combination Additional
- Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib
- Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients
- Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.
- Previous treatment with a PKC inhibitor
- Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
- Known symptomatic brain metastases
- Adverse events from prior anti-cancer therapy that have not resolved
- Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
- Active infection requiring ongoing therapy
- Recent surgery or radiotherapy
- Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
- Females who are pregnant or breastfeeding
- Impaired cardiac function
- Treatment with prohibited medications that cannot be discontinued prior to study entry
- For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin Crizotinib Combination Additional Exclusion Criteria:
- Prior therapy directly targeting ALK, MET, or ROS1
- Spinal cord compression
- History of pneumonitis or interstitial lung disease
- History of syncope
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment PK Substudy (optional) with Pravastatin Additional Exclusion Criteria:
- Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1
- Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin
- Any contraindication associated to the use of statins or hypersensitivity component of pravastatin
- Active liver disease DDI Cocktail Substudy Additional Exclusion Criteria:
- Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.
- Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit/grapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.
- Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
- Moderate and strong inhibitors of CYP2A4/5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
- Intake of strong or moderate inducers of CYP3A4/5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Iowa City, Iowa, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Sydney, New South Wales, Australia
- Woolloongabba, Australia
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Iowa City, Iowa, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.