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COMPLETEDPHASE1

Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

NCT02492737•Agios Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation

Detailed Description

The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-881 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs or the patient is removed at the discretion of the investigator.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be ≥18 years of age
•Patients must have documented IDH1 and/or IDH2 gene-mutated disease
•Patients must have an advanced hematologic malignancy with an IDH1 and/or IDH2 mutation
•Patient must be able to understand and willing to sign an informed consent
•Patients must have ECOG PS of 0 to 2
•Patients must have adequate hepatic function as evidenced by serum total bilirubin ≤1.5 upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic involvement
•Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to involvement by the neoplasm under consideration for treatment
•Patients must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or Creatinine clearance 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation
•Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer
•Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy. Patients with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal (i.e., who have not menstruated at all) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Exclusion Criteria

•Patients who have undergone HSCT within 60 days
•Patients who received systemic anticancer therapy or radiotherapy \<14 days prior to their first day of study drug administration
•Patients who received an investigational agent \<14 days prior
•Patients who are pregnant or breast feeding
•Patients with an active severe infection who require anti-infective therapy or with an unexplained fever \>38.5°C during Screening visits or on their first day of study drug administration (at the discretion of the Investigator, patients with tumor fever may be enrolled)
•Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1
•Patients with a history of myocardial infarction within the last 6 months
•Patients with known unstable or uncontrolled angina pectoris
•Patients with a known history of severe and/or uncontrolled ventricular arrhythmias
•Patients with QTc interval ≥450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events
+4 more criteria

Locations (6)

Aurora, Colorado, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

New York, New York, United States

Houston, Texas, United States

Villejuif, France

Key Dates

Start Date

August 7, 2015

Primary Completion Date

March 21, 2018

Completion Date

March 21, 2018

Last Updated

March 8, 2019

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia (AML)Myelodysplastic SyndromeHematologic Malignancies

Interventions

AG881

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

Inclusion Criteria

Exclusion Criteria

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