Clinical Trials in Italy / NCT04771130
Recruiting
Phase 1/2
A Study of BGB-11417 in Participants With Myeloid Malignancies
NCT04771130 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm
Investigational drug(s) / intervention(s)
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
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.
More BeOne Medicines trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04771130 on ClinicalTrials.gov ↗ ← All trials in Italy