A Study of BGB-11417 in Participants With Myeloid Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
BeOne Medicines
Study ID
NCT04771130
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BGB-11417 — DRUG
    Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
  • Azacitidine — DRUG
    Intravenous or subcutaneous administration for 7 days.
  • Posaconazole — DRUG
    Oral administration for 8 days on second cycle only.
  • BGB-11417 — DRUG
    Oral administration for 28 days on a 28-day cycle.
  • BGB-11417 — DRUG
    Oral administration for 10, 14 or 21 days on a 28-day

Study Details

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Key Dates

First listed
Feb 25, 2021
Start date
May 24, 2021
Status verified
Jul 2026
Primary completion
Feb 8, 2028
Completion
Feb 8, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Parts 1 and 2: AML Cohorts
    Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.
  • Experimental: Parts 1 and 2: MDS Cohorts
    Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.
  • Experimental: Part 3: AML and MDS Cohorts
    Participants with AML and MDS will receive BGB-11417 and azacitidine on a 28-day cycle. A subset of the participants will receive a modified second cycle of treatment to explore drug-drug interactions (DDI) with posaconazole.
  • Experimental: Part 3: AML and MDS Cohort
    Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.

Primary Outcome Measure

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-3012-
Tampa General HospitalTampaFlorida33606-3571-
Upmc Hillman Cancer Center(Univ of Pittsburgh)PittsburghPennsylvania15232-1309-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Medical College of WisconsinMilwaukeeWisconsin53226-3522-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CATampa General Hospital· Tampa, FLUpmc Hillman Cancer Center(Univ of Pittsburgh)· Pittsburgh, PAMd Anderson Cancer Center· Houston, TXMedical College of Wisconsin· Milwaukee, WI

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