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Anti-tumor agent

1 for Chondrosarcoma

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post study treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post study treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) in all study participants

Secondary outcome measures

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

71%

Nausea

57%

Fatigue

57%

Diarrhoea

43%

Urinary tract infection

43%

Insomnia

43%

Anaemia

43%

Somnolence

29%

Blood bilirubin increased

29%

Pyrexia

29%

Cough

29%

Leukocytosis

29%

Dry eye

29%

Constipation

29%

Vomiting

29%

Decreased appetite

29%

Hyperbilirubinaemia

14%

Alanine aminotransferase increased

14%

Bacteraemia

14%

Wound complication

14%

Lung infection

14%

Dehydration

14%

Herpes simplex

14%

Hypomagnesaemia

14%

Syncope

14%

Arthralgia

14%

Hyperglycaemia

14%

Oral infection

14%

Contusion

14%

Lymphocyte count decreased

14%

Hypercalcaemia

14%

Hypoxia

14%

Back pain

14%

Thrombocytopenia

14%

Palpitations

14%

Aspiration

14%

Pneumonia aspiration

14%

Apnoea

14%

Respiratory failure

14%

Gait disturbance

14%

Hyponatraemia

14%

Flank pain

14%

Tumour pain

14%

Metabolic encephalopathy

14%

Confusional state

14%

Abdominal discomfort

14%

Pleural effusion

14%

Chills

14%

Productive cough

14%

Nasal congestion

14%

Dysphagia

14%

Angina pectoris

14%

Sinus tachycardia

14%

Abdominal distension

14%

Abdominal pain upper

14%

Flatulence

14%

Salivary hypersecretion

14%

Amylase increased

14%

Aspartate aminotransferase increased

14%

Blood bilirubin unconjugated increased

14%

Blood creatinine increased

14%

International normalised ratio increased

14%

Hypoalbuminaemia

14%

Muscle spasms

14%

Muscle tightness

14%

Muscular weakness

14%

Musculoskeletal pain

14%

Headache

14%

Tremor

14%

Anxiety

14%

Dyspnoea

14%

Oropharyngeal pain

14%

Wheezing

14%

Butterfly rash

14%

Hypertension

14%

Hypotension

14%

Venous thrombosis limb

14%

Conjunctivitis

14%

Oral candidiasis

14%

Pharyngitis

14%

Upper respiratory tract infection

14%

Wound

14%

Hypocalcaemia

14%

Hypokalaemia

14%

Dizziness

14%

Facial paresis

14%

Hemiparesis

14%

Scrotal erythema

14%

Non-cardiac chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Enasidenib 400 mg

Enasidenib 100 mg

Enasidenib 200 mg

Enasidenib 650 mg

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

~560

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,411 Total Patients Enrolled

18 Trials studying Chondrosarcoma

1,562 Patients Enrolled for Chondrosarcoma

Charalampos Floudas, M.D.Principal InvestigatorNational Cancer Institute (NCI)

5 Previous Clinical Trials

651 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial open to individuals who are below 70 years of age?

"This clinical trial welcomes individuals aged 18 and older, with an upper age limit of 120 years."

Answered by AI

Are there any available slots for patients to participate in this research study?

"According to the details provided on clinicaltrials.gov, this particular clinical trial is not currently seeking participants. The trial was initially posted on December 25th, 2023 and underwent its most recent revision on December 19th, 2023. However, it's worth noting that there are currently a total of 3415 other studies actively enrolling patients at this time."

Answered by AI

Am I eligible to enroll in this clinical trial?

"Eligible participants for this clinical trial should have a diagnosis of chondrosarcoma and fall within the age range of 18 to 120 years old. The study aims to enroll approximately 30 patients in total."

Answered by AI

What is the level of safety associated with substance 1 when consumed by individuals?

"Based on our assessment, the safety rating for this trial is 2 out of 3. As a Phase 2 trial, there is existing data supporting its safety, although efficacy has not been established yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

2024. "Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176989.

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