RecruitingPhase 2NCT06176989

Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

Phase II Study of Enasidenib in IDH2-mutated Malignant Sinonasal and Skull Base Tumors


Sponsor

National Cancer Institute (NCI)

Enrollment

40 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Cancers of the nasal cavity or skull base are rare. They often are not diagnosed until they are at an advanced stage, and they often spread to other parts of the body. These cancers may have mutations in a gene called IDH2. Researchers want to find out if a drug (enasidenib) that targets the IDH2 mutation can help people with these cancers. Objective: To test enasidenib in people with cancers of the nasal cavity or skull base. Eligibility: People aged 18 years and older with rare cancers of the nasal cavity or the base of the skull. Their cancer must have an IDH2 gene mutation, and it must have recurred locally or spread to other parts of the body. These cancers can include sinonasal undifferentiated carcinoma; olfactory neuroblastoma; sinonasal large-cell neuroendocrine carcinoma; poorly differentiated sinonasal adenocarcinoma; or chondrosarcoma. Design: Participants will be screened. They will have a physical exam with blood and urine tests and tests of their heart function. They will have imaging scans of their brain, skull base, neck, chest, abdomen, and pelvis. A sample of tumor tissue will be collected. Enasidenib is a tablet taken by mouth with a glass of water. Participants will take the drug once a day, every day, in 28-day cycles. They will not have resting periods between cycles. Participants will visit the clinic on the first day of each cycle to receive the tablets they will need to take at home until the beginning of the next cycle. They will keep a diary to record the time of each dose they take. Participants may remain in the study as long as the drug is helping them....


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing enasidenib — a targeted drug that blocks a mutated enzyme called IDH2 — in people with rare, advanced cancers of the nasal cavity and skull base (including sinonasal undifferentiated carcinoma, esthesioneuroblastoma, and related tumors) that carry IDH2 mutations and have progressed after prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic sinonasal or skull base tumor - Your tumor has a specific IDH2 mutation (R140 or R172) - Your cancer has progressed after at least one prior systemic treatment - Your cancer cannot be cured by surgery or radiation - You have measurable disease on imaging and adequate organ function **You may NOT be eligible if...** - Your tumor does not have an IDH2 mutation - You have not yet tried other systemic treatments - You have significant liver, kidney, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnasidenib

100mg PO (orally) once daily, on days 1-28 of a 28-day cycle


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT06176989