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IDH2 Inhibitor

Enasidenib for Blood Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study treatment to the data cut-off date of 01 september 2017; median time on follow-up in phase 2 was 5.8 months (range 0.4 to 22.5 months).

Awards & highlights

Study Summary

This trial is testing a new drug for safety and effectiveness in people with advanced blood cancers. The first part is to find the best dose, and the second part is to see if the drug works in people with a certain type of cancer.

Who is the study for?

Adults over 18 with advanced blood cancers and specific IDH2 gene mutations can join this trial. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception if they can have children, and not have had certain treatments or conditions that could interfere with the study.Check my eligibility

What is being tested?

Enasidenib is being tested in adults with blood cancers like AML that are resistant to treatment. The trial has two parts: finding the safest dose for Enasidenib (Phase 1) and then checking how well it works at that dose for treating AML (Phase 2).See study design

What are the potential side effects?

Possible side effects of Enasidenib include issues affecting liver function, digestive system disturbances, fatigue, changes in heart rhythm or blood pressure, allergic reactions to its components, and an increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study treatment to the data cut-off date of 01 september 2017; median time on follow-up in phase 2 was 5.8 months (range 0.4 to 22.5 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study treatment to the data cut-off date of 01 september 2017; median time on follow-up in phase 2 was 5.8 months (range 0.4 to 22.5 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment to the data cut-off date of 01 september 2017; median time on follow-up in phase 2 was 5.8 months (range 0.4 to 22.5 months). for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)

Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events

+3 more

Secondary outcome measures

Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML

Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Platelet Transfusion Independence Post-baseline

Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline

+79 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: enasidenibExperimental Treatment1 Intervention

enasidenib administered orally. Multiple doses will be administered to determine the RP2D.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enasidenib

2020

Completed Phase 2

~560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,626 Total Patients Enrolled

Agios Pharmaceuticals, Inc.Industry Sponsor

52 Previous Clinical Trials

3,861 Total Patients Enrolled

Mark Frattini, MDStudy DirectorCelgene Corporation

Media Library

Enasidenib (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01915498 — Phase 1 & 2

Blood Cancers Research Study Groups: enasidenib

Blood Cancers Clinical Trial 2023: Enasidenib Highlights & Side Effects. Trial Name: NCT01915498 — Phase 1 & 2

Enasidenib (IDH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01915498 — Phase 1 & 2

Frequently Asked Questions

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

Are there current opportunities to join this research endeavor?

"Contradictory to expectations, clinicaltrials.gov does not indicate that this study is actively trying to get participants involved at the moment. Initially posted on 8/27/2013 and last updated 7/11/2022, there are still 2550 other trials currently looking for patients."

Answered by AI

Is this an unprecedented research endeavor?

"Since 2013, Enasidenib has been the subject of much research. The original trial was conducted by Celgene and involved 345 participants. This led to Phase 1 & 2 drug approval being granted for this substance. Nowadays there are 24 active trials on record spread over 84 cities in 28 countries."

Answered by AI

Has there been any prior research conducted with Enasidenib?

"Initially investigated in 2013 at Local Institution - 201, enasidenib has since been the subject of 6 completed clinical trials. 24 current studies are underway with a large number centred around New york City."

Answered by AI

In how many locations can this research be accessed?

"Participants for this trial can be enrolled from Cornell University Weill Medical College in New york, Oregon Health and Science University OHSU in Portland, Sarah Cannon Research Institute Drug Development Unit in Nashville as well as 19 other research centres."

Answered by AI

What is the total participation in this investigation?

"At this time, no more participants are being accepted for this medical trial. Initially posted on August 27th 2013 and recently updated on July 11th 2022, the study is now closed. However, there are 2526 trials currently recruiting patients with hematologic neoplasms and 24 studies that use Enasidenib actively looking for enrollments."

Answered by AI

What is the ultimate objective of this clinical investigation?

"The primary assessment of this clinical trial, which will conclude 28 days following the administration of the first dose, focuses on Treatment Emergent Adverse Events (TEAEs). Secondary outcomes include Investigator Assessed Overall Response Rate (ORR) by Total Daily Dose and Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML. Lastly, Phase 1 Dose Expansion aims to measure the rate of Complete Response and Complete Responses With Incomplete Hematological Recovery (CR/CRi/CRp)."

Answered by AI

Recent research and studies

BloodJournal

Enasidenib in Mutant IDH2 Relapsed or Refractory Acute Myeloid Leukemia

Stein, Eytan M., Courtney D. DiNardo, Daniel A. Pollyea, Amir T. Fathi, Gail J. Roboz, Jessica K. Altman, Richard M. Stone, et al.. 2017. “Enasidenib in Mutant IDH2 Relapsed or Refractory Acute Myeloid Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood-2017-04-779405.

LeukemiaJournal

Enasidenib, an Inhibitor of Mutant IDH2 Proteins, Induces Durable Remissions in Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Pollyea, Daniel A., Martin S. Tallman, Stéphane de Botton, Hagop M. Kantarjian, Robert Collins, Anthony S. Stein, Mark G. Frattini, et al.. 2019. “Enasidenib, an Inhibitor of Mutant IDH2 Proteins, Induces Durable Remissions in Older Patients with Newly Diagnosed Acute Myeloid Leukemia”. Leukemia. Springer Science and Business Media LLC. doi:10.1038/s41375-019-0472-2.

JAMA OncologyJournal

Differentiation Syndrome Associated with Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2

Fathi, Amir T., Courtney D. DiNardo, Irina Kline, Laurie Kenvin, Ira Gupta, Eyal C. Attar, Eytan M. Stein, Stephane de Botton, and for the AG221-C-001 Study Investigators. 2018. “Differentiation Syndrome Associated with Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2017.4695.

Nature MedicineJournal