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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
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
Secondary ID [1] 0 0
2021-003285-12
Secondary ID [2] 0 0
BGB-11417-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Myelodysplastic Syndromes 0 0
Myelodysplastic/Myeloproliferative Neoplasm 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
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, 14 or 21 days on a 28-day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
Primary outcome [2] 0 0
Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Approximately 24 months
Primary outcome [3] 0 0
Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate
Timepoint [3] 0 0
Approximately 24 months
Primary outcome [4] 0 0
Part 3 MDS Cohort: Modified Overall Response (mOR) Rate
Timepoint [4] 0 0
Approximately 24 months
Primary outcome [5] 0 0
Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole
Timepoint [5] 0 0
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
Primary outcome [6] 0 0
Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole
Timepoint [6] 0 0
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
Primary outcome [7] 0 0
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 Administered Alone and When Co-administered With Posaconazole
Timepoint [7] 0 0
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)
Primary outcome [8] 0 0
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs
Timepoint [8] 0 0
Cycle 2
Primary outcome [9] 0 0
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs
Timepoint [9] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR With Partial Hematologic Recovery (CRh)
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Parts 1 And 2 MDS Cohort: mOR Rate
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417
Timepoint [3] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [4] 0 0
Parts 1 And 2: Terminal Half-life (t1/2) Of Azacitidine When Coadministered With BGB-11417
Timepoint [4] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [5] 0 0
Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417
Timepoint [5] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [6] 0 0
Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417
Timepoint [6] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [7] 0 0
Parts 1 And 2: Apparent Total Clearance Of Azacitidine From Plasma (CL/F) When Coadministered With BGB-11417
Timepoint [7] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [8] 0 0
Parts 1 And 2: Apparent Volume Of Distribution (Vz/F) Of Azacitidine When Coadministered With BGB-11417
Timepoint [8] 0 0
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
Secondary outcome [10] 0 0
Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine
Timepoint [10] 0 0
Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
Secondary outcome [11] 0 0
Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine
Timepoint [11] 0 0
Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
Secondary outcome [12] 0 0
Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine
Timepoint [12] 0 0
Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose
Secondary outcome [13] 0 0
Part 3: Number Of Participants Experiencing TEAEs
Timepoint [13] 0 0
Approximately 24 months
Secondary outcome [14] 0 0
Part 3: Complete Response Rate
Timepoint [14] 0 0
Approximately 24 months
Secondary outcome [15] 0 0
Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate
Timepoint [15] 0 0
Approximately 24 months
Secondary outcome [16] 0 0
Part 3 AML Cohort: Overall Response Rate (ORR)
Timepoint [16] 0 0
Approximately 24 months
Secondary outcome [17] 0 0
Part 3 AML Cohort: Duration Of Response (DOR)
Timepoint [17] 0 0
Approximately 24 months
Secondary outcome [18] 0 0
Part 3 AML Cohort: Time To Response (TTR)
Timepoint [18] 0 0
Approximately 24 months
Secondary outcome [19] 0 0
Part 3 Event-free Survival (EFS)
Timepoint [19] 0 0
Approximately 24 months
Secondary outcome [20] 0 0
Part 3 Overall Survival (OS)
Timepoint [20] 0 0
Approximately 24 months
Secondary outcome [21] 0 0
Part 3 AML Cohort: Number of Participants with Transfusion Independence
Timepoint [21] 0 0
Approximately 24 months
Secondary outcome [22] 0 0
Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E)
Timepoint [22] 0 0
Approximately 24 months
Secondary outcome [23] 0 0
Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P)
Timepoint [23] 0 0
Approximately 24 months
Secondary outcome [24] 0 0
Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N)
Timepoint [24] 0 0
Approximately 24 months
Secondary outcome [25] 0 0
Part 3 MDS Cohort: Number of participants with Transfusion Independence
Timepoint [25] 0 0
Approximately 24 months
Secondary outcome [26] 0 0
Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine
Timepoint [26] 0 0
Cycle 1 Day 1 and Cycle 2 Day 5 (predose and 4 and 6 hours postdose)
Secondary outcome [27] 0 0
Part 3 MDS cohort: Partial Hematologic Recovery CRh
Timepoint [27] 0 0
Approximately 24 months
Secondary outcome [28] 0 0
Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery
Timepoint [28] 0 0
Approximately 24 months
Secondary outcome [29] 0 0
Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417
Timepoint [29] 0 0
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose)
Secondary outcome [30] 0 0
Part 3 MDS (Treated with Monotherapy): Modified Overall Response
Timepoint [30] 0 0
Approximately 24 months
Secondary outcome [31] 0 0
Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417
Timepoint [31] 0 0
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/02/2028
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Orange Health Hospital - Orange
Recruitment hospital [4] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [7] 0 0
Monash Health - Clayton
Recruitment hospital [8] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [12] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [13] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2800 - Orange
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4224 - Tugun
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Gansu
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Henan
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jiangxi
Country [14] 0 0
China
State/province [14] 0 0
Sichuan
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
China
State/province [16] 0 0
Zhejiang
Country [17] 0 0
France
State/province [17] 0 0
Lille
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Germany
State/province [20] 0 0
Leipzig
Country [21] 0 0
Germany
State/province [21] 0 0
Ulm
Country [22] 0 0
Italy
State/province [22] 0 0
Bologna
Country [23] 0 0
Italy
State/province [23] 0 0
Meldola
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul Teugbyeolsi
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Takapuna
Country [28] 0 0
New Zealand
State/province [28] 0 0
Wellington
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Salamanca
Country [31] 0 0
Spain
State/province [31] 0 0
Sevilla
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Edinburgh
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Greater Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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