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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04771130
Registration number
NCT04771130
Ethics application status
Date submitted
23/02/2021
Date registered
25/02/2021
Titles & IDs
Public title
A Study of BGB-11417 in Participants With Myeloid Malignancies
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Scientific title
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
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Secondary ID [1]
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2021-003285-12
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Secondary ID [2]
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BGB-11417-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Myelodysplastic Syndromes
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Myelodysplastic/Myeloproliferative Neoplasm
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-11417
Treatment: Drugs - Azacitidine
Treatment: Drugs - Posaconazole
Treatment: Drugs - BGB-11417
Treatment: Drugs - BGB-11417
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.
Treatment: Drugs: BGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
Treatment: Drugs: Azacitidine
Intravenous or subcutaneous administration for 7 days.
Treatment: Drugs: Posaconazole
Oral administration for 8 days on second cycle only.
Treatment: Drugs: BGB-11417
Oral administration for 28 days on a 28-day cycle.
Treatment: Drugs: BGB-11417
Oral administration for 10 or 21 days on a 28-day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
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Primary outcome [2]
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Part 1 And 2: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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Timepoint [2]
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Approximately 24 months
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Primary outcome [3]
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Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate
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Assessment method [3]
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CR plus CRh will be defined as the proportion of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.
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Timepoint [3]
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Approximately 24 months
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Primary outcome [4]
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Part 3 MDS Cohort: Modified Overall Response (mOR) Rate
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Assessment method [4]
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The mOR will be defined as the proportion of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic/myeloproliferative neoplasm (MDS/MPN).
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Timepoint [4]
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Approximately 24 months
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Primary outcome [5]
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Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable (AUC0-t) Of BGB-11417 When Co-administered With Posaconazole
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Assessment method [5]
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Timepoint [5]
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Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
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Primary outcome [6]
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Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Coadministered With Posaconazole
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Assessment method [6]
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Timepoint [6]
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Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
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Primary outcome [7]
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Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Co-administered With Posaconazole
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Assessment method [7]
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0
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Timepoint [7]
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Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)
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Primary outcome [8]
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Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs
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Assessment method [8]
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Timepoint [8]
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Cycle 2
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Primary outcome [9]
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Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs
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Assessment method [9]
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Timepoint [9]
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Approximately 24 months
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Secondary outcome [1]
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Parts 1 And 2 AML Cohort: CR Plus CRh Rate
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Assessment method [1]
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Timepoint [1]
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Approximately 24 months
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Secondary outcome [2]
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Parts 1 And 2 MDS Cohort: mOR Rate
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Assessment method [2]
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Timepoint [2]
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Approximately 24 months
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Secondary outcome [3]
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Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417
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Assessment method [3]
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Timepoint [3]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [4]
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Parts 1 And 2: t1/2 Of Azacitidine When Coadministered With BGB-11417
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Assessment method [4]
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Timepoint [4]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [5]
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Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417
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Assessment method [5]
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Timepoint [5]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [6]
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Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417
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Assessment method [6]
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Timepoint [6]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [7]
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Parts 1 And 2: Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of Azacitidine When Coadministered With BGB-11417
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Assessment method [7]
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Timepoint [7]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [8]
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Parts 1 And 2: Apparent Volume Of Distribution (Vz/F) Of Azacitidine When Coadministered With BGB-11417
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Assessment method [8]
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Timepoint [8]
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Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
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Secondary outcome [9]
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Parts 1 And 2: Steady-state AUC From Time Zero To Time Of Last Measurable Concentration (AUClast,ss) Of BGB-11417 When Coadministered With Azacitidine
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Assessment method [9]
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Timepoint [9]
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Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
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Secondary outcome [10]
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Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine
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Assessment method [10]
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Timepoint [10]
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Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
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Secondary outcome [11]
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Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine
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Assessment method [11]
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Timepoint [11]
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Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
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Secondary outcome [12]
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Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine
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Assessment method [12]
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0
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Timepoint [12]
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Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
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Secondary outcome [13]
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Part 3: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing TEAEs
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Assessment method [13]
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0
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Timepoint [13]
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Approximately 24 months
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Secondary outcome [14]
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Part 3: Complete Response
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Assessment method [14]
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CR will be defined as the proportion of participants whose BOR is CR. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.
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Timepoint [14]
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Approximately 24 months
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Secondary outcome [15]
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Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate
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Assessment method [15]
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CRi will be defined as the proportion of participants whose BOR is CRi.
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Timepoint [15]
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Approximately 24 months
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Secondary outcome [16]
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Part 3 AML Cohort: Overall Response Rate (ORR)
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Assessment method [16]
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The ORR will include participants whose BOR include CR, CRi, PR, and morphologic leukemia-free state.
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Timepoint [16]
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Approximately 24 months
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Secondary outcome [17]
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Part 3 AML Cohort: Duration Of Response (DOR)
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Assessment method [17]
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DOR will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.
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Timepoint [17]
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Approximately 24 months
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Secondary outcome [18]
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Part 3 AML Cohort: Time To Response (TTR)
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Assessment method [18]
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TTR will be defined as the time from treatment initiation to the first documented response and will include CR, CR plus CRi, OR, and CR plus CRh.
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Timepoint [18]
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Approximately 24 months
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Secondary outcome [19]
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Part 3 AML Cohort: Event-free Survival (EFS)
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Assessment method [19]
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EFS will be defined as the time from treatment initiation to disease progression, treatment failure, relapse (hematologic relapse for AML) for those who have treatment success, or death due to any cause, whichever happens first.
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Timepoint [19]
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Approximately 24 months
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Secondary outcome [20]
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Part 3 AML Cohort: Overall Survival (OS)
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Assessment method [20]
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OS will be defined as the time from treatment initiation to death. OS will be analyzed using the same methods as the EFS analysis except for the censoring rules.
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Timepoint [20]
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Approximately 24 months
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Secondary outcome [21]
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Part 3 AML Cohort: Number Of Participants Receiving BGB-11417 In Combination With Posaconazole Experiencing TEAEs
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Assessment method [21]
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Timepoint [21]
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Approximately 24 months
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Secondary outcome [22]
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Part 3 AML Cohort: Number of Participants with Transfusion Independence
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Assessment method [22]
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Transfusion independence will be defined as the proportion of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.
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Timepoint [22]
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Approximately 24 months
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Secondary outcome [23]
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Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E)
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Assessment method [23]
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The proportion of participants whose BOR is HI-E
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Timepoint [23]
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Approximately 24 months
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Secondary outcome [24]
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Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P)
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Assessment method [24]
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The proportion of participants whose BOR is HI-P
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Timepoint [24]
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Approximately 24 months
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Secondary outcome [25]
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Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N)
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Assessment method [25]
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The proportion of participants whose BOR is HI-N will be reported.
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Timepoint [25]
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Approximately 24 months
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Secondary outcome [26]
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Part 3 MDS Cohort: Number of participants with Transfusion Independence
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Assessment method [26]
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Transfusion independence will be defined as the proportion of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.
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Timepoint [26]
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Approximately 24 months
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Secondary outcome [27]
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Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine
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Assessment method [27]
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Timepoint [27]
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Cycle 1 Day 1 and Cycle 2 Day 5 (predose and 4 and 6 hours postdose)
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Secondary outcome [28]
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Part 3 MDS cohort: Partial Hematologic Recovery CRh
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Assessment method [28]
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Proportion of participants with partial hematologic recovery will be reported
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Timepoint [28]
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Approximately 24 months
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Secondary outcome [29]
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Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery
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Assessment method [29]
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Proportion of participants with Complete Response + Morphologic complete Remission with Partial Hematologic Recovery will be reported.
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Timepoint [29]
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Approximately 24 months
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Secondary outcome [30]
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Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417
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Assessment method [30]
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0
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Timepoint [30]
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Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose)
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Secondary outcome [31]
0
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Part 3 MDS (Treated with Monotherapy): Modified Overall Response
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Assessment method [31]
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Proportion of participants with modified overall response including CR, marrow CR (mCR) or partial remission (PR)
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Timepoint [31]
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Approximately 24 months
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Secondary outcome [32]
0
0
Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417
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Assessment method [32]
0
0
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Timepoint [32]
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Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose)
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Eligibility
Key inclusion criteria
Key
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. A diagnosis of acute promyelocytic leukemia.
2. Prior malignancy within the past 2 years, except for curatively treated 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 or azacitidine except for participants who meet HMA-failure criteria
5. Known central nervous system involvement by leukemia.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
260
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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0
St George Hospital - Kogarah
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Recruitment hospital [3]
0
0
Orange Health Hospital - Orange
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Recruitment hospital [4]
0
0
Gold Coast University Hospital - Southport
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Recruitment hospital [5]
0
0
John Flynn Private Hospital - Tugun
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Recruitment hospital [6]
0
0
Monash Health - Clayton
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Recruitment hospital [7]
0
0
St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [8]
0
0
Austin Health - Heidelberg
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Recruitment hospital [9]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [10]
0
0
Fiona Stanley Hospital - Murdoch
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Recruitment hospital [11]
0
0
Linear Clinical Research - Nedlands
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Recruitment hospital [12]
0
0
One Clinical Research - Nedlands
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Recruitment postcode(s) [1]
0
0
2139 - Concord
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Recruitment postcode(s) [2]
0
0
2217 - Kogarah
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Recruitment postcode(s) [3]
0
0
2800 - Orange
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Recruitment postcode(s) [4]
0
0
4215 - Southport
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Recruitment postcode(s) [5]
0
0
4224 - Tugun
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Recruitment postcode(s) [6]
0
0
3168 - Clayton
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Recruitment postcode(s) [7]
0
0
3065 - Fitzroy
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Recruitment postcode(s) [8]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [9]
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0
3004 - Melbourne
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Recruitment postcode(s) [10]
0
0
6150 - Murdoch
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Recruitment postcode(s) [11]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Maryland
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Pennsylvania
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Wisconsin
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Country [7]
0
0
China
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State/province [7]
0
0
Beijing
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Country [8]
0
0
China
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State/province [8]
0
0
Gansu
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Country [9]
0
0
China
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State/province [9]
0
0
Guangdong
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Country [10]
0
0
China
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State/province [10]
0
0
Henan
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Country [11]
0
0
China
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State/province [11]
0
0
Hubei
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Country [12]
0
0
China
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State/province [12]
0
0
Jiangsu
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Country [13]
0
0
China
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State/province [13]
0
0
Jiangxi
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Country [14]
0
0
China
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State/province [14]
0
0
Sichuan
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Country [15]
0
0
China
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State/province [15]
0
0
Tianjin
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Country [16]
0
0
China
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State/province [16]
0
0
Zhejiang
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Country [17]
0
0
Germany
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State/province [17]
0
0
Leipzig
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Country [18]
0
0
Korea, Republic of
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State/province [18]
0
0
Seoul Teugbyeolsi
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Country [19]
0
0
New Zealand
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State/province [19]
0
0
Takapuna
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Country [20]
0
0
New Zealand
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State/province [20]
0
0
Wellington
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Country [21]
0
0
Spain
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State/province [21]
0
0
Barcelona
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Country [22]
0
0
Spain
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State/province [22]
0
0
Salamanca
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Country [23]
0
0
Spain
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State/province [23]
0
0
Sevilla
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Country [24]
0
0
Spain
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State/province [24]
0
0
Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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) .
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Trial website
https://clinicaltrials.gov/study/NCT04771130
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Trial related presentations / publications
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Public notes
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Contacts
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BeiGene
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1.877.828.5568
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04771130