Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT02074839
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes
  • Other IDH1-mutated Positive Hematologic Malignancies
  • Relapsed or Refractory Acute Myeloid Leukemia (AML)
  • Untreated AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AG-120 — DRUG
    AG-120 administered continuously as a single agent dosed orally every day of a 28-day cycle. Subjects may continue treatment with AG-120 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.

Study Details

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 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 four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Key Dates

Start date
Mar 1, 2014
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
291 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AG-120
    AG-120 administered continuously as a single agent dosed orally every day of a 28-day cycle.

Primary Outcome Measure

Safety/tolerability: incidence of adverse events. [ Time Frame: up to 26 weeks, on average ]

Central Contacts

  • Institut de Recherches Internationales Servier Clinical Studies Department
    +33 1 55 72 43 66
    [email protected]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Mayo Clinic-AZPhoenixArizona85259-
City of HopeDuarteCalifornia91010-
University of California-Los AngelesLos AngelesCalifornia90095-
University of California-San FranciscoSan FranciscoCalifornia94143-
University of Colorado DenverAuroraColorado80045-
Mayo Clinic-JacksonvilleJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
Moffit Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Northwestern University Medical HospitalChicagoIllinois60611-
John Hopkins Cancer CenterBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Karmanos Cancer CenterDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
Cornell Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Duke Cancer CenterDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44124-
Ohio State UniversityColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sarah Cannon Research InstituteNashvilleTennessee37203-
UT Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic-AZ· Phoenix, AZCity of Hope· Duarte, CAUniversity of California-Los Angeles· Los Angeles, CAUniversity of California-San Francisco· San Francisco, CAUniversity of Colorado Denver· Aurora, CO

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