A Study of BGB-11417 in Participants With Myeloid Malignancies (NCT04771130) — UK Trial Details

Condition(s) studied

Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm

Investigational drug(s) / intervention(s)

BGB-11417AzacitidinePosaconazoleBGB-11417BGB-11417

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: 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 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.

Primary outcome measure(s)

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) — Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — Approximately 24 months
Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate — Approximately 24 months
CR plus CRh will be defined as the percentage 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.
Part 3 MDS Cohort: Modified Overall Response (mOR) Rate — Approximately 24 months
The mOR will be defined as the percentage 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).
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 — Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole — Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
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 — Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs — Cycle 2
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs — Approximately 24 months

Trial sites (47)

Facility	City	Region	Status
City of Hope National Medical Center	Duarte	California	Terminated
Tampa General Hospital	Tampa	Florida	Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)	Pittsburgh	Pennsylvania	Recruiting
Md Anderson Cancer Center	Houston	Texas	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting
Concord Repatriation General Hospital	Concord	New South Wales	Recruiting
St George Hospital	Kogarah	New South Wales	Recruiting
Orange Health Hospital	Orange	New South Wales	Recruiting
Gold Coast University Hospital	Southport	Queensland	Recruiting
Monash Health	Clayton	Victoria	Recruiting
St Vincents Hospital Melbourne	Fitzroy	Victoria	Recruiting
Austin Health	Heidelberg	Victoria	Recruiting
The Alfred Hospital	Melbourne	Victoria	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
Linear Clinical Research	Nedlands	Western Australia	Recruiting
One Clinical Research	Nedlands	Western Australia	Recruiting
Peking University Peoples Hospital	Beijing	Beijing Municipality	Recruiting
The First Hospital of Lanzhou University	Lanzhou	Gansu	Recruiting
Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong	Recruiting
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	Recruiting
The Second Peoples Hospital of Shenzhen	Shenzhen	Guangdong	Completed
Henan Cancer Hospital	Zhengzhou	Henan	Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi	Recruiting
West China Hospital, Sichuan University	Chengdu	Sichuan	Recruiting
Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin Municipality	Completed
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
Hopital Claude Huriez Chu Lille	Lille	France	Recruiting
Hopital Larchet	Nice	France	Recruiting
Hopital Saint Louis	Paris	France	Recruiting
Universitaetsklinikum Leipzig Aor	Leipzig	Germany	Recruiting
Universitaetsklinikum Ulm	Ulm	Germany	Recruiting
Policlinico Sorsola Malpighi, Aou Di Bologna	Bologna	Italy	Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst	Meldola	Italy	Recruiting
Niguarda Cancer Center Division of Hematology	Milan	Italy	Recruiting
North Shore Hospital	Auckland	New Zealand	Recruiting
Aotearoa Clinical Trials	Auckland	New Zealand	Recruiting
Wellington Regional Hospital (Ccdhb)	Wellington	New Zealand	Recruiting
Samsung Medical Center	GangnamGu	Seoul Teugbyeolsi	Recruiting

+ 7 more sites — see the full list on the official registry below.

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