Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors (NCT06176989) | Clinical Trial Compass
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
United States40 participantsStarted 2024-03-04
Plain-language 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....
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Histologically or cytologically confirmed locally advanced or metastatic SNUC, ONB, LCNEC, SNAC, and CS with documented somatic (tumor) IDH2 mutations R140 or R172. Primary tumors must be located in the sinonasal cavity and/or skull base.
* Locally advanced disease must not be amenable to potentially curative surgery/radiotherapy.
* Must have recurred or progressed following prior systemic therapy administered in the recurrent or metastatic setting. Any number of prior systemic therapies is allowed.
* Measurable disease, per RECIST 1.1. Lesions in a previously irradiated field are considered measurable if they have been demonstrated as progressing during or following radiotherapy.
* Age \>=18 years.
* ECOG performance status 0-2
* Adequate organ and marrow function as defined below:
* hemoglobin \>=9 g/dL (PRBC transfusion allowed)
* absolute neutrophil count (ANC) \>=1,000/mcL
* platelets \>=75,000/mcL
* total bilirubin \<= 1.5 x institutional upper limit of normal (iULN) (\<=3x in the presence of Gilbert s syndrome or a UGT1A1 gene mutation)
* AST/ALT \<=1.5 x iULN (\<=2.5 x iULN if liver metastasis)
* Serum Creatinine \<=1.5 x iULN OR
* Creatinine Clearance \>=40 mL/min by Cockroft-Gault GFR estimation for subjects with serum creatinine levels \<=1.5 X iULN
* Participants with treated brain or central nervous system metastases are eligible if follow-up brain imaging after at least 4 weeks following CNS-directed therapy shows no eviden…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) in all study participants