ClinicalTrials.gg
RecruitingNCT06176989Updated Nov 5, 2026

Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

A Phase 2 interventional study of Enasidenib in Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma and Metastatic Sinonasal Adenocarcinoma, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Updated Nov 3, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 58 studies in Chondrosarcoma with a site in United States — 9 open to participants now, 19 under way, none of them phase 3. Chondrosarcoma · United States.

Planned enrollment
24th of 47
40 · median 40
Started
2024
with 2 others
Phase 2
23 of 58
2 open now
Primary completion
2027-12
later than 14 of 17 live
Registered
56th of 58
by date
Lead sponsor
5 of 58
National Cancer Institute (NCI)

Among the 58 studies in Chondrosarcoma with a site in United States, this one is the 24th largest by planned enrollment of the 47 interventional ones, is one of 3 that started in 2024, is one of 23 in phase 2, reaches primary completion later than 14 of the 17 other live ones, and was the 56th registered.

By phase

58 studies; the count open now beside each. This study's row is marked.

Phase 2this study23 · 2 open
Phase 115 · 1 open
Observational7 · 4 open
Phase 1/26 · 0 open
No phase4 · 1 open
Phase 32 · 0 open
Other kind1 · 1 open

By the year they started

First in 1992; this study’s year is marked. 3 started in 2024.

Size and results

Median enrollment 40 across the 47 interventional studies, 189 across the 7 observational. Of the 39 that completed or were terminated, 15 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 58 studies in Chondrosarcoma with a site in United States, or all of them as a file.
02

Study 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....

Read the detailed description

Background:

  • Sinonasal undifferentiated carcinoma (SNUC) and olfactory neuroblastoma (ONB) are rare malignant sinonasal and skull base tumors, a group that also includes sinonasal adenocarcinoma, squamous cell carcinoma, large cell neuroendocrine carcinoma, sinonasal papilloma, chondrosarcoma (CS), chordoma and others.
  • These malignancies are often diagnosed at a locally advanced stage. They tend to invade locally and have high rates of regional spread to the neck, and distally to the lungs and bones. For early locoregional disease multimodality treatment is used: surgery with postoperative radiotherapy, with or without induction chemotherapy. Treatment approaches for metastatic disease are largely based on institutional case series and consist largely of systemic chemotherapy.
  • Recent genomic studies have reported isocitrate dehydrogenase-2 (IDH2) hotspot mutations in up to 87% of SNUC, 17% of ONB, and in 12% of chondrosarcomas; it has also been reported in sinonasal large-cell neuroendocrine carcinoma (LCNEC) and poorly differentiated sinonasal adenocarcinoma (SNAC).
  • IDH2 hotspot mutations have been identified in acute myeloid leukemia, glioblastoma, myelodysplastic syndromes, and cholangiocarcinoma.
  • Enasidenib is an orally bioavailable, selective and potent inhibitor of mutated IDH2, which is approved in relapsed IDH2 mutated (IDH2m) AML.
  • Inhibition of mutated IDH2 may be clinically useful in IDH2m malignant sinonasal and skull base tumors.

Objectives:

- To estimate the overall progression free survival (PFS) based on treatment with enasidenib in all study participants with IDH2m malignant sinonasal and skull base tumors.

Eligibility:

  • Histologically or cytologically confirmed locally advanced or metastatic SNUC, ONB, LCNEC, SNAC, and CS with documented somatic (tumor) IDH2 mutations R140 or R172.

    • Eligible primary tumor locations are sinonasal cavity and skull base.
    • Locally advanced disease must not be amenable to potentially curative surgery/radiotherapy.
  • Measurable disease, per RECIST 1.1
  • Age >= 18 years
  • ECOG Performance Status 0-2
  • Adequate organ function

Design:

  • Single-arm Phase II trial to determine PFS in participants with recurrent or metastatic IDH2m malignant sinonasal and skull base tumors.
  • Enasidenib will be given at a dose of 100mg orally once daily until progressive disease or unacceptable toxicity.
03

Conditions studied

  • Metastatic Chondrosarcoma
  • Locally Advanced Chondrosarcoma
  • Metastatic Sinonasal Adenocarcinoma
  • Locally Advanced Sinonasal Adenocarcinoma
  • Metastatic Large-cell Neuroendocrine Carcinoma
  • Locally Advanced Large-cell Neuroendocrine Carcinoma
  • Metastatic Olfactory Neuroblastoma
  • Locally Advanced Olfactory Neuroblastoma
  • Metastatic Sinonasal Undifferentiated Carcinoma
  • Locally Advanced Sinonasal Undifferentiated Carcinoma

Keywords

  • R140 mutation
  • R172 mutation
  • Small Molecule Inhibitor
04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • or cytologically confirmed locally advanced or 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.
  • , per 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.
  • performance status 0-2
  • Adequate organ and marrow function as defined below:

    • >=9 g/dL (PRBC transfusion allowed)
    • (ANC) >=1,000/mcL
    • >=75,000/mcL
    • total \<= 1.5 x institutional (iULN) (\<=3x in the presence of Gilbert s syndrome or a UGT1A1 gene mutation)
    • /ALT \<=1.5 x iULN (\<=2.5 x iULN if liver metastasis)
    • Serum Creatinine \<=1.5 x iULN OR
    • >=40 mL/min by Cockroft-Gault 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 evidence of progression.
  • Participants positive for (HIV) must have >= 200 cells per cubic millimeter at enrollment, be on stable antiretroviral therapy for at least 4 weeks and have no reported opportunistic infections or Castleman's disease within 12 months prior to treatment.
  • Participants with evidence of chronic virus (HBV) infection, must have HBV viral load that is undetectable on suppressive therapy, if indicated.
  • Participants with evidence of infection, must have viral load that is undetectable.
  • Individuals of (IORP*) and individuals with partners who can bear children must agree to abstain from sexual intercourse or to use 1 highly effective method of during the study and for at least 2 months following the last dose of enasidenib. A highly effective form of contraception is one of the following: hormonal contraception (e.g., oral contraceptive pills, intravaginal ring, transdermal patch, injection, implant); intrauterine device (IUD); tubal ligation; or a partner with a vasectomy.
  • Participants who are nursing or plan to nurse must agree to discontinue/postpone nursing while on study therapy and for at least 2 months after the last dose.
  • Ability of participant to understand and willingness to sign a written document.
  • Willingness to provide blood samples and undergo of tumor for research purposes. Participants may be exempt from biopsy.
  • Participants must co-enroll in companion protocol study #18-DC-0051 entitled "Biospecimen procurement for NIDCD clinical protocols". A separate informed consent will be obtained from study participants for this study.
  • Participants with ONB must co-enroll in companion protocol #21-C-0009 entitled "A Natural History Study of Children and Adults with Olfactory Neuroblastoma". A separate informed consent will be obtained from study participants for this study.

    • IORP: any person who has experienced menarche and has not had hysterectomy or bilateral oophorectomy or is not (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \<50 years old need follicle stimulating hormone FSH in the post-menopausal range)

Exclusion criteria

EXCLUSION CRITERIA:

  • Prior treatment with IDH1/2 inhibitor.
  • Use of other agents within 3 weeks or 5 half-lives prior to first treatment administration.
  • Systemic anticancer treatment within 3 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved or be minimal and not constitute a safety risk. Note: Bisphosphonates and denosumab are permitted medications.
  • 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.
  • Participants with new or progressive (active) or .
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib.
  • Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to first treatment administration.
  • Participants taking the following sensitive cytochrome P450 (CYP) substrate medications that have a narrow therapeutic range are excluded from the study unless they can be transferred to other medications prior to enrolling: warfarin, phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline and tizanidine (CYP1A2). Excluded medications should not be given within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study medication. Other CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP1A2 substrates may be given concurrently if medically necessary.
  • Participants taking sensitive substrates of P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), OAT1, OATP1B1, OATP1B3, and OCT2 should be excluded from the study unless the substrate medication can be dose modified according to the package insert of the substrate (if applicable) and adverse events can be closely monitored during concurrent administration. Alternately, participants can be transferred to other medications prior to enrolling. Excluded medications should not be given within 3 weeks or 5 half-lives (whichever is shorter) prior to the first of study medication.
  • Participants taking medications that are known to prolong the unless the participant can be transferred to other medications at least 5 half-lives prior to the start of the study treatment. If equivalent medication is not available, QTc will be closely monitored
  • Impaired cardiovascular function or cardiovascular disease, including, but not limited to, any of the following:

    • cerebral vascular accident/stroke (\< 3 months prior to enrollment),
    • uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg)
    • acute coronary syndromes (including myocardial infarction \< 6 months prior to enrollment, unstable angina),
    • Symptomatic congestive heart failure
    • Rate-corrected QT (QTc using Fridericia formula [QTcF]) >450 msec
    • Severe/uncontrolled ventricular arrhythmia
  • Known short-gut syndrome, gastroparesis, or other conditions that limit the ingestion of gastrointestinal absorption of drugs administered orally.
  • Active infection requiring treatment with parenteral antibiotics.
  • History of second within 3 years prior to enrollment except for the following: adequately treated localized basal cell or squamous skin cancer, cervical carcinoma in situ, superficial bladder cancer, other localized malignancy which has been adequately treated or malignancy which does not require active systemic treatment (e.g., low risk CLL).
  • Participant pregnancy
  • Uncontrolled intercurrent illness (including psychiatric) or social situations, that may limit interpretation of results or increase risk to the participant:
Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    1

    Participants with IDH2 mutated (R140/R172) malignant sinonasal and skull base tumors.

    Drug: Enasidenib

Interventions

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

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) in all study participants

    The date of first treatment until the date of disease progression or death without progression

    Time frame: up to 5 years post study treatment

Secondary outcomes

  1. safety

    Adverse events assessed per CTCAE version 5

    Time frame: from study treatment initiation up to 28 days post study treatment

  2. clinical benefit rate (CBR: CR+PR+SD>4 months) in participants with IDH2m SNUC

    Fraction of participants experiencing CBR = CR+PR+ SD \> 16 weeks

    Time frame: up to 5 years post study treatment

  3. PFS in non-SNUC IDH2m tumors

    The date of first treatment until the date of disease progression or death without progression

    Time frame: up to 5 years post study treatment

  4. Overall survival (OS) in non-SNUC IDH2m tumors

    The date of first treatment until date of death or last follow-up

    Time frame: up to 5 years post study treatment

  5. clinical benefit rate (CBR: CR+PR+SD>4 months) in participants with non-SNUC IDH2m tumors

    Fraction of participants experiencing CBR = CR+PR+ SD \> 16 weeks

    Time frame: up to 5 years post study treatment

  6. Overall survival (OS) in participants with IDH2m SNUC

    The date of first treatment until date of death or last follow-up

    Time frame: up to 5 years post study treatment

  7. PFS in participants with IDH2m SNUC

    The date of first treatment until the date of disease progression or death without progression

    Time frame: up to 5 years post study treatment

  8. Correlate UGTIA1 genotypes with toxicity

    Descriptive statistics of AE occurence per UGTIA1 genotype

    Time frame: from study treatment initiation up to 28 days post study treatment

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD will be shared. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing. This study will comply with the NIH Genomic Data Sharing (GDS) Policy, which applies to all new and ongoing NIH IRP-funded research, as of January 25, 2015, that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Therefore, unlinked genomic data will be deposited in public genomic databases such as dbGaP in compliance with the NIH Genomic Data Sharing Policy.@@@@@@@@@@@@

Access criteria: Data from this study may be requested by contacting the PI. Genomic data are made available via dbGaP through requests to the data custodians.@@@@@@

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2023
First posted
Dec 20, 2023
StartActual
Mar 4, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2030
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
3 inclusion criteria edited, 1 removed
What changed in the criteria
Inclusion criteria
  • RemovedMust have recurred or progressed following prior systemic therapy administered in the recurrent or metastatic setting. Any number of prior systemic therapies is allowed.
  • EditedParticipants positive for human immunodeficiency virus (HIV) must have CD4 count >= 200 cells per cubic millimeter at enrollment, be on stable antiretroviral therapy for at least 4 weeks and have no reported opportunistic infections or Castleman 's disease within 12 months prior to treatment.
  • EditedParticipants must co-enroll in companion protocol study #18-DC-0051 entitled "Biospecimen procurement for NIDCD clinical protocols ". A separate informed consent will be obtained from study participants for this study.
  • EditedParticipants with ONB must co-enroll in companion protocol #21-C-0009 entitled "A Natural History Study of Children and Adults with Olfactory Neuroblastoma ". A separate informed consent will be obtained from study participants for this study.
Nov 3, 2026
Show all 3 updates
  1. Nov 5, 2026
    Minor edits only
    + 1 other change: verification date
  2. Nov 3, 2026
    Eligibility 3 inclusion criteria edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedMust have recurred or progressed following prior systemic therapy administered in the recurrent or metastatic setting. Any number of prior systemic therapies is allowed.
    • EditedParticipants positive for human immunodeficiency virus (HIV) must have CD4 count >= 200 cells per cubic millimeter at enrollment, be on stable antiretroviral therapy for at least 4 weeks and have no reported opportunistic infections or Castleman 's disease within 12 months prior to treatment.
    • EditedParticipants must co-enroll in companion protocol study #18-DC-0051 entitled "Biospecimen procurement for NIDCD clinical protocols ". A separate informed consent will be obtained from study participants for this study.
    • EditedParticipants with ONB must co-enroll in companion protocol #21-C-0009 entitled "A Natural History Study of Children and Adults with Olfactory Neuroblastoma ". A separate informed consent will be obtained from study participants for this study.
    + 1 other change: description
  3. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06176989
Responsible party
Sponsor
First posted
Dec 20, 2023
Start date
Mar 4, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Nov 5, 2026

Study contacts

NCI Medical Oncology Referral Office
Contact
ncimo_referrals@nih.gov
(240) 760-6050
Charalampos Floudas, M.D.
Contact
charalampos.floudas@nih.gov
(240) 474-1575
Charalampos Floudas, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Enasidenib

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