A Study of ONO-7475 in Patients With Acute Leukemias

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT03176277
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Acute Leukemia
  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • ONO-7475 3mg once daily — DRUG
    Part A initial dose level
  • ONO-7475 6mg once daily — DRUG
    Part A 2nd dose level
  • ONO-7475 10mg once daily — DRUG
    Part A 3rd dose level
  • ONO-7475 6mg + Venetoclax (70-400mg) — DRUG
    Part D ONO-7475 + Venetoclax Combination

Study Details

\[Updated\]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.

Key Dates

Start date
Jun 26, 2017
Status verified
Jul 2024
Primary completion
Dec 1, 2022
Completion
Jan 20, 2023

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-7475 3mg once daily
    Part A Initial dose level
  • Experimental: ONO-7475 6mg once daily
    Part A 2nd dose level
  • Experimental: ONO-7475 10mg once daily
    Part A 3rd dose level
  • Experimental: ONO-7475 6mg + Venetoclax (70-400mg)
    Part D ONO-7475 + Venetoclax combination

Primary Outcome Measure

Incidence of Adverse Events (Part A) [ Time Frame: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months). ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of CaliforniaLos AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
Yale University School of Medicine - Yale Cancer CenterNorth HavenConnecticut06510-
University of Florida (UF) - Shands Cancer CenterGainesvilleFlorida32610-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
The Winship Cancer Institute Emory UniversityAtlantaGeorgia30322-
Augusta University Medical CenterAugustaGeorgia30912-
Norton Cancer InstituteLouisvilleKentucky40207-
University of MichiganAnn ArborMichigan48109-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
Wake Forest UniversityWinston-SalemNorth Carolina27157-
The Ohio State University (OSU)ColumbusOhio43210-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Medical University of South Carolina - Hollins Cancer CenterCharlestonSouth Carolina29425-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Los Angeles, CA

By research site
University of California· Los Angeles, CAUniversity of Southern California· Los Angeles, CAYale University School of Medicine - Yale Cancer Center· North Haven, CTUniversity of Florida (UF) - Shands Cancer Center· Gainesville, FLMayo Clinic - Jacksonville· Jacksonville, FLThe Winship Cancer Institute Emory University· Atlanta, GA

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