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Recruiting Phase 1/2 NCT04771130

A Study of BGB-11417 in Participants With Myeloid Malignancies

Phase 1/2 – combined early trial
Conditions: Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm

Sponsor: BeiGene

trial.available_in: БГ
Overview
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) .
Who can participate
Key Inclusion Criteria: 1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria: * AML, nonacute promyelocytic leukemia * MDS * MDS/MPN 2. Eastern Cooperative Oncology Group performance status of 0 to 2. 3. Adequate organ function defined as: * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort) * Adequate liver function 4. Life expectancy of \> 12 weeks. 5. Ability to comply with the requirements of the study. Key Exclusion Criteria: 1. A diagnosis of acute promyelocytic leukemia. 2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer) 3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation. 4. Prior therapy with a B-cell lymphoma-2 inhibitor 5. Known central nervous system involvement by leukemia. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Interventions
BGB-11417
DRUG
Azacitidine
DRUG
Posaconazole
DRUG
BGB-11417
DRUG
BGB-11417
DRUG
Locations 46
Australia (11)
Monash Health
Clayton , Victoria
Concord Repatriation General Hospital
Concord , New South Wales
St Vincents Hospital Melbourne
Fitzroy , Victoria
Austin Health
Heidelberg , Victoria
St George Hospital
Kogarah , New South Wales
The Alfred Hospital
Melbourne , Victoria
Fiona Stanley Hospital
Murdoch , Western Australia
Linear Clinical Research
Nedlands , Western Australia
One Clinical Research
Nedlands , Western Australia
Orange Health Hospital
Orange , New South Wales
Gold Coast University Hospital
Southport , Queensland
China (12)
Peking University Peoples Hospital
Beijing , Beijing Municipality
West China Hospital, Sichuan University
Chengdu , Sichuan
Guangdong Provincial Peoples Hospital
Guangzhou , Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou , Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
The First Hospital of Lanzhou University
Lanzhou , Gansu
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang , Jiangxi
The Second Peoples Hospital of Shenzhen
Shenzhen , Guangdong
COMPLETED
The First Affiliated Hospital of Soochow University
Suzhou , Jiangsu
Tianjin Medical University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
COMPLETED
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan , Hubei
Henan Cancer Hospital
Zhengzhou , Henan
France (3)
Hopital Claude Huriez Chu Lille
Lille
Hopital Larchet
Nice
Hopital Saint Louis
Paris
Germany (2)
Universitaetsklinikum Leipzig Aor
Leipzig
Universitaetsklinikum Ulm
Ulm
Italy (3)
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola
Niguarda Cancer Center Division of Hematology
Milan
New Zealand (2)
North Shore Hospital
Auckland
Wellington Regional Hospital (Ccdhb)
Wellington
South Korea (2)
Samsung Medical Center
GangnamGu , Seoul Teugbyeolsi
Severance Hospital Yonsei University Health System
SeodaemunGu , Seoul Teugbyeolsi
Spain (4)
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Virgen Del Rocio
Seville
Hospital Universitari I Politecnic La Fe
Valencia
United Kingdom (2)
Edinburgh Cancer Centre
Edinburgh
The Christie Hospital
Greater Manchester
United States (5)
City of Hope National Medical Center
Duarte , California
TERMINATED
Md Anderson Cancer Center
Houston , Texas
Medical College of Wisconsin
Milwaukee , Wisconsin
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh , Pennsylvania
Tampa General Hospital
Tampa , Florida
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.05.2021
Completion date
08.02.2028
Registry ID
NCT04771130
Source
clinicaltrials.gov
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