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RECRUITING
NCT04771130
PHASE1/PHASE2

A Study of BGB-11417 in Participants With Myeloid Malignancies

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

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) .

Official title: A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2021-05-24

Completion Date

2028-02-08

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

BGB-11417

Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.

DRUG

Azacitidine

Intravenous or subcutaneous administration for 7 days.

DRUG

Posaconazole

Oral administration for 8 days on second cycle only.

DRUG

BGB-11417

Oral administration for 28 days on a 28-day cycle.

DRUG

BGB-11417

Oral administration for 10, 14 or 21 days on a 28-day

Locations (46)

City of Hope National Medical Center

Duarte, California, United States

Tampa General Hospital

Tampa, Florida, United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Md Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Orange Health Hospital

Orange, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

One Clinical Research

Nedlands, Western Australia, Australia

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Second Peoples Hospital of Shenzhen

Shenzhen, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hopital Claude Huriez Chu Lille

Lille, France

Hopital Larchet

Nice, France

Hopital Saint Louis

Paris, France

Universitaetsklinikum Leipzig Aor

Leipzig, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, Italy

Niguarda Cancer Center Division of Hematology

Milan, Italy

North Shore Hospital

Auckland, New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Edinburgh Cancer Centre

Edinburgh, United Kingdom

The Christie Hospital

Greater Manchester, United Kingdom