Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT04657081
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Decitabine and Cedazuridine (ASTX727) — DRUG
    Route of administration: oral in the form of a tablet
  • Venetoclax — DRUG
    Route of administration: oral in the form of a tablet

Study Details

The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B.

Key Dates

Start date
Feb 9, 2021
Status verified
Dec 2025
Primary completion
Sep 30, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral administration of ASTX727 and Venetoclax combination
    Cycle 1: ASTX727 according to a prescribed dosing regimen and venetoclax on day 1 (100 mg daily), day 2 (200 mg daily), and days 3-28 (400 mg daily) of a 28-day cycle. Cycle 2 and beyond: ASTX727 according to a prescribed dosing regimen and venetoclax on days 1-28 (400 mg daily) of a 28-day cycle.

Primary Outcome Measure

Pharmacokinetic parameter: AUC0-24 [ Time Frame: On Days 5 and 15 in Cycle 2 (28 days per cycle) ]

Locations (24)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford UniversityPalo AltoCalifornia94306-
Yale UniversityNew HavenConnecticut06510-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
Boca Raton Clinical ResearchPlantationFlorida33322-
The University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
University of Massachusetts, Memorial Medical CenterWorcesterMassachusetts01655-
Health Midwest Ventures Group, Inc.Kansas CityMissouri64132-
Hackensack University of Medical CenterHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of RochesterRochesterNew York14627-
The Research Foundation of the State University of New York (SUNY)SyracuseNew York13210-
East Carolina UniversityGreenvilleNorth Carolina27834-
The Ohio State UniversityColumbusOhio43210-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt University Medical CenterNashvilleTennessee37232-6307-
MD Anderson Cancer CenterHoustonTexas77030-
Baylor Scott & White Research InstituteTempleTexas76508-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAStanford University· Palo Alto, CAYale University· New Haven, CTBaptist MD Anderson Cancer Center· Jacksonville, FLBoca Raton Clinical Research· Plantation, FLThe University of Chicago Medical Center· Chicago, IL

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