Metastatic ChondrosarcomaPhase 2NCT06176989
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
A Phase 2 study testing Enasidenib in people with Metastatic Chondrosarcoma and Locally Advanced Chondrosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma
- What is being tested?
- Enasidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 evidence of progression.
- Participants 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.
- Participants with evidence of chronic hepatitis B virus (HBV) infection, must have HBV viral load that is undetectable on suppressive therapy, if indicated.
- Participants with evidence of HCV infection, must have viral load that is undetectable.
- Individuals of reproductive potential (IORP*) and individuals with partners who can bear children must agree to abstain from sexual intercourse or to use 1 highly effective method of contraception 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 informed consent document.
- Willingness to provide blood samples and undergo biopsy 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 postmenopausal (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)
Who cannot join
- Prior treatment with IDH1/2 inhibitor.
- Use of other investigational 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) brain metastases or leptomeningeal disease.
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- 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 QT interval 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 clinically significant 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 malignancy 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: Phase II Study of Enasidenib in IDH2-mutated Malignant Sinonasal and Skull Base Tumors
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.
Read more
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.
- 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
- 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.
- Conditions
- Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma, Metastatic Large-cell Neuroendocrine Carcinoma, Locally Advanced Large-cell Neuroendocrine Carcinoma
- Being tested
- Enasidenib
- Keywords
- R140 mutation, R172 mutation, Small Molecule Inhibitor
- Medical subject headings
- Chondrosarcoma, Esthesioneuroblastoma, Olfactory, Sinonasal undifferentiated carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnasidenibDrug
100mg PO (orally) once daily, on days 1-28 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants with IDH2 mutated (R140/R172) malignant sinonasal and skull base tumors. Receives: Drug: Enasidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) in all study participants
The date of first treatment until the date of disease progression or death without progression
Measured: up to 5 years post study treatment
Secondary outcomes (8)
safety
Adverse events assessed per CTCAE version 5
Measured: from study treatment initiation up to 28 days post study treatment
clinical benefit rate (CBR: CR+PR+SD>4 months) in participants with IDH2m SNUC
Fraction of participants experiencing CBR = CR+PR+ SD > 16 weeks
Measured: up to 5 years post study treatment
PFS in non-SNUC IDH2m tumors
The date of first treatment until the date of disease progression or death without progression
Measured: up to 5 years post study treatment
Overall survival (OS) in non-SNUC IDH2m tumors
The date of first treatment until date of death or last follow-up
Measured: up to 5 years post study treatment
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
Measured: up to 5 years post study treatment
Overall survival (OS) in participants with IDH2m SNUC
The date of first treatment until date of death or last follow-up
Measured: up to 5 years post study treatment
PFS in participants with IDH2m SNUC
The date of first treatment until the date of disease progression or death without progression
Measured: up to 5 years post study treatment
Correlate UGTIA1 genotypes with toxicity
Descriptive statistics of AE occurence per UGTIA1 genotype
Measured: from study treatment initiation up to 28 days post study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start4 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charalampos Floudas, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176989
- Sponsor's protocol ID
- 10001552
- Other IDs
- 001552-C
- Status last verified
- 13 Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.@@@@@@
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Enasidenib in IDH2-mutated Malignant Sinonasal and Skull Base Tumors
- ClinicalTrials.gov ID
- NCT06176989
- Acronym / sponsor ID
- 10001552
- Conditions
- Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma, Metastatic Large-cell Neuroendocrine Carcinoma, Locally Advanced Large-cell Neuroendocrine Carcinoma
- Keywords
- R140 mutation, R172 mutation, Small Molecule Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EnasidenibParticipants with IDH2 mutated (R140/R172) malignant sinonasal and skull base tumors. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (23 listed)
- Prior treatment with IDH1/2 inhibitor.
- Use of other investigational 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enasidenib100mg PO (orally) once daily, on days 1-28 of a 28-day cycle | Drug | 1 |
Primary outcome
Progression Free Survival (PFS) in all study participants
Time frame: up to 5 years post study treatment
The date of first treatment until the date of disease progression or death without progression
8 secondary outcomes
safety
Time frame: from study treatment initiation up to 28 days post study treatment
clinical benefit rate (CBR: CR+PR+SD>4 months) in participants with IDH2m SNUC
Time frame: up to 5 years post study treatment
PFS in non-SNUC IDH2m tumors
Time frame: up to 5 years post study treatment
Overall survival (OS) in non-SNUC IDH2m tumors
Time frame: up to 5 years post study treatment
clinical benefit rate (CBR: CR+PR+SD>4 months) in participants with non-SNUC IDH2m tumors
Time frame: up to 5 years post study treatment
Overall survival (OS) in participants with IDH2m SNUC
Time frame: up to 5 years post study treatment
PFS in participants with IDH2m SNUC
Time frame: up to 5 years post study treatment
Correlate UGTIA1 genotypes with toxicity
Time frame: from study treatment initiation up to 28 days post study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.@@@@@@
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charalampos Floudas, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enasidenib in people with Metastatic Chondrosarcoma and Locally Advanced Chondrosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI Medical Oncology Referral Office ((240) 760-6050, ncimo_referrals@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) in all study participants (time frame: up to 5 years post study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.