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Anti-tumor agent

Enasidenib for Sinonasal and Skull Base Cancer

Phase 2
Recruiting
Led By Charalampos Floudas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
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.
Must not have
Large-field radiotherapy within 4 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved (except xerostomia) or be minimal and not constitute a safety risk.
Major surgery within 2 weeks prior to first treatment administration. If participant underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Minimally invasive procedures are permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug called enasidenib to see if it can help people with rare cancers of the nasal cavity or skull base. These cancers often have a specific gene mutation called IDH

Who is the study for?
Adults over 18 with rare cancers in the nasal cavity or skull base, specifically those with an IDH2 gene mutation. The cancer must have returned after treatment or spread elsewhere. Eligible types include sinonasal undifferentiated carcinoma, olfactory neuroblastoma, large-cell neuroendocrine carcinoma of the sinus, poorly differentiated adenocarcinoma of the sinus, and chondrosarcoma.
What is being tested?
The trial is testing Enasidenib—a drug targeting IDH2 mutations—in patients with advanced-stage nasal cavity or skull base cancers. Participants will take Enasidenib orally every day in continuous 28-day cycles and attend clinic visits at the start of each cycle to receive their medication supply.
What are the potential side effects?
Potential side effects for Enasidenib are not specified here but may include typical reactions to cancer medications such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My cancer is in the nose/skull base and has specific IDH2 mutations.
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My advanced cancer cannot be treated with surgery or radiation aimed at curing it.
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My cancer has returned or worsened after treatment in the advanced stage.
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My hemoglobin level is at least 9 g/dL.
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I have chronic hepatitis B but it's under control with treatment.
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My hepatitis C virus is undetectable.
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I am 18 years old or older.
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My cancer can be measured and has grown despite previous radiation.
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My kidneys work well enough, with a creatinine clearance rate of at least 40 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major radiation therapy in the last 4 weeks and any side effects are minimal.
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I have not had major surgery in the last 2 weeks or have fully recovered if I did.
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I have not had a heart attack or unstable angina in the last 6 months.
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I have symptoms of heart failure.
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I am currently on IV antibiotics for an infection.
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I have new or worsening brain metastases or leptomeningeal disease.
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I do not have serious heart problems.
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I do not have severe heart rhythm problems.
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I have a condition that affects how my body absorbs medication taken by mouth.
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I have been treated with an IDH1/2 inhibitor before.
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I am not taking medications like warfarin or phenytoin, or can switch them before joining.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) in all study participants
Secondary study objectives
Correlate UGTIA1 genotypes with toxicity
Overall survival (OS) in non-SNUC IDH2m tumors
Overall survival (OS) in participants with IDH2m SNUC
+5 more

Side effects data

From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739
67%
Asthenia
67%
Decreased appetite
67%
Cough
67%
Dyspnoea
33%
Pyrexia
33%
Hyperglycaemia
33%
Musculoskeletal chest pain
33%
Tachypnoea
33%
Sinus tachycardia
33%
Hypoalbuminaemia
33%
Partial seizures
33%
Dysphagia
33%
Disease progression
33%
Sepsis
33%
Dehydration
33%
Mental status changes
33%
Pneumonia aspiration
33%
Anaemia
33%
Supraventricular tachycardia
33%
Constipation
33%
Nausea
33%
Fatigue
33%
Oedema peripheral
33%
Skin bacterial infection
33%
Fall
33%
Shunt malfunction
33%
Blood alkaline phosphatase increased
33%
Blood lactate dehydrogenase increased
33%
Lipase decreased
33%
Costochondritis
33%
Musculoskeletal pain
33%
Osteonecrosis
33%
Dizziness
33%
Dysuria
33%
Dyspnoea exertional
33%
Acne
33%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enasidenib 100 mg
Enasidenib 200 mg
Enasidenib 400 mg
Enasidenib 650 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Participants with IDH2 mutated (R140/R172) malignant sinonasal and skull base tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enasidenib
2020
Completed Phase 2
~610

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,030 Total Patients Enrolled
19 Trials studying Chondrosarcoma
3,036 Patients Enrolled for Chondrosarcoma
Charalampos Floudas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
655 Total Patients Enrolled
~20 spots leftby Dec 2027
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