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A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

NCT03720366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-28

No results posted yet for this study

Summary

This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation.

The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2).

Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2).

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

enasidenib

enasidenib

DRUG

Arm 1 probes

caffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole

DRUG

Arm 2 Probes

digoxin and rosuvastatin

DRUG

Arm 3 probes

pioglitazone

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2023-09-22
Completion
2023-12-22
FDA Drug
Yes

Countries

  • Australia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720366 on ClinicalTrials.gov