A Study of BGB-11417 in Participants With Myeloid Malignancies
NCT ID: NCT04771130
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
260 participants
INTERVENTIONAL
2021-05-24
2028-02-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parts 1 and 2: AML Cohorts
Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.
BGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
Azacitidine
Intravenous or subcutaneous administration for 7 days.
Parts 1 and 2: MDS Cohorts
Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.
Azacitidine
Intravenous or subcutaneous administration for 7 days.
BGB-11417
Oral administration for 10, 14 or 21 days on a 28-day
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.
BGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
Azacitidine
Intravenous or subcutaneous administration for 7 days.
Posaconazole
Oral administration for 8 days on second cycle only.
Part 3: AML and MDS Cohort
Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.
BGB-11417
Oral administration for 28 days on a 28-day cycle.
Interventions
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BGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
Azacitidine
Intravenous or subcutaneous administration for 7 days.
Posaconazole
Oral administration for 8 days on second cycle only.
BGB-11417
Oral administration for 28 days on a 28-day cycle.
BGB-11417
Oral administration for 10, 14 or 21 days on a 28-day
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Other Identifiers
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2021-003285-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508881-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20213416
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-11417-103
Identifier Type: -
Identifier Source: org_study_id