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New treatment option for Metastatic Chondrosarcoma
Official title Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
ClinicalTrials.gov ID: NCT06176989
What this study is testing
What is Enasidenib?
Enasidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic chondrosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically or cytologically confirmed locally advanced or metastatic SNUC, ONB, LCNEC, SNAC, and CS with documented somatic (tumor) IDH2...
- 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...
- Measurable disease, per RECIST 1.1. Lesions in a previously irradiated field are considered measurable if they have been demonstrated as progressing...
- Age \>=18 years.
You likely can't join if
- 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...
- Large-field radiotherapy within 4 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved (except...
- Major surgery within 2 weeks prior to first treatment administration. If participant underwent major surgery, they must have recovered adequately...
- Participants with new or progressive (active) brain metastases or leptomeningeal disease.
See the full eligibility criteria
Who can 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...
- 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 people 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- Participants with new or progressive (active) brain metastases or leptomeningeal disease.
- 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...
- 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...
- 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...
- 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...
- 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...
- Participant pregnancy
- Uncontrolled intercurrent illness (including psychiatric) or social situations, that may limit interpretation of results or increase risk to the participant:
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.