RecruitingPhase 1Phase 2NCT04771130

A Study of BGB-11417 in Participants With Myeloid Malignancies

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

Sponsor

BeiGene

Enrollment

260 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm

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) .

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BGB-11417 for people with certain blood cancers including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and overlap conditions. BGB-11417 targets a protein called BCL-2 that helps cancer cells survive, and researchers are studying it alone and with other treatments. **You may be eligible if...** - You have been diagnosed with AML (not the APL subtype), MDS, or MDS/MPN (a condition that has features of both MDS and another blood disorder) - You have reasonable kidney and liver function - You have a life expectancy of more than 12 weeks - You are able to follow the study requirements **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) - You have had another cancer recently that wasn't fully cured - You have very poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-11417

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

DRUGAzacitidine

Intravenous or subcutaneous administration for 7 days.

DRUGPosaconazole

Oral administration for 8 days on second cycle only.

DRUGBGB-11417

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

DRUGBGB-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, 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

View Full Details on ClinicalTrials.gov

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NCT04771130

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