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IDH2 Inhibitor

Enasidenib for Liver Disease

Phase 1
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 the time the icf is signed until day 36 (+/- 2 days) or within 28 days after the last dose of ip, whichever time frame is longer
Awards & highlights

Study Summary

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time the icf is signed until day 36 (+/- 2 days) or within 28 days after the last dose of ip, whichever time frame is longer
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time the icf is signed until day 36 (+/- 2 days) or within 28 days after the last dose of ip, whichever time frame is longer for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics - AUC0-t (CC-90007)
Pharmacokinetics - AUC0-∞ (CC-90007)
Pharmacokinetics - Cmax (CC-90007)
+1 more
Secondary outcome measures
Adverse Events (AEs)
Pharmacokinetics - AUC0-t (AGI-16903)
Pharmacokinetics - AUC0-∞ (AGI-16903)
+2 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%
0%
Study treatment Arm
Enasidenib 400 mg
Enasidenib 100 mg
Enasidenib 200 mg
Enasidenib 650 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enasidenib (CC-90007) tabletExperimental Treatment1 Intervention
Participants will receive one 100 mg enasidenib (CC-90007) tablet the morning of Day 1 which will be administered in the fasted state.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enasidenib
2020
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,931 Total Patients Enrolled
Leon Carayannopoulos, MDStudy DirectorBristol-Myers Squibb
14 Previous Clinical Trials
518 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,957 Total Patients Enrolled

Frequently Asked Questions

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

What goals is this medical experiment aiming to achieve?

"The Celgene-sponsored trial has a main objective of assessing the pharmacokinetics (AUC0-t) of CC-90007 over an extended period. Supplementary objectives include quantifying AUC0–t, AUC 0–∞, and Tmax for AGI-16903."

Answered by AI

Has a similar study been conducted before this one?

"Presently, 24 live experiments for Enasidenib are taking place in 28 countries and 84 cities. Celgene initiated the first study of their drug back in 2013 with a total of 345 participants who completed Phase 1 & 2 trials successfully. Since then, 6 additional research projects have been launched."

Answered by AI

Are there any identified dangers associated with administering Enasidenib?

"The safety of Enasidenib is rated at 1 given the limited information available from Phase I studies, which indicate potential efficacy but lack comprehensive data on its security."

Answered by AI

To whom is this research opportunity available?

"The requirements for inclusion in this trial are hepatic impairment and a patient aged between 40 and 75 years-old. Currently, up to 48 patients will be accepted into the study."

Answered by AI

Is the age cutoff for this research endeavor 40 or older?

"This scientific trial is open to those who are between the ages of 40 and 75."

Answered by AI

Could you elucidate what other investigations have been undertaken with Enasidenib?

"As of 2013, enasidenib has been the subject of 6 completed trials. At present, there are 24 studies in progress, with a considerable number taking place in Miami, Florida."

Answered by AI

To what extent are participants being included in this clinical investigation?

"Affirmative, the clinicaltrials.gov record indicates that this research endeavor is currently enrolling members. It was initially published on November 13th 2020 and its information has been recently revised on November 7th 2022. The project requires a total of 48 individuals to be recruited from 3 separate locations."

Answered by AI

Are any new participants being taken on for this clinical experiment?

"As indicated on clinicaltrials.gov, the team behind this medical study is actively seeking volunteers. The trial was originally announced on November 13th 2020 and its most recent update occurred seven months later in July 2022."

Answered by AI
~9 spots leftby Apr 2025