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JOURNAL ONKOLOGIE – STUDIE

A Study of BGB-11417 in Participants With Myeloid Malignancies

Rekrutierend

NCT-Nummer:
NCT04771130

Studienbeginn:
Mai 2021

Letztes Update:
19.10.2023

Wirkstoff:
BGB-11417, azacitidine, Posaconazole

Indikation (Clinical Trials):
Myelodysplastic Syndromes, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
BeiGene

Collaborator:
-

Kontakt

Studienlocations
(3 von 41)

Universitaetsklinikum Leipzig Aor
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Maryland Oncology Hematology, Pa
21044 Columbia
United StatesRekrutierend» Google-Maps
Upmc Hillman Cancer Center(Univ of Pittsburgh)
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Md Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Medical College of Wisconsin
53226 Milwaukee
United StatesRekrutierend» Google-Maps
Concord Repatriation General Hospital
2139 Concord
AustraliaRekrutierend» Google-Maps
Gold Coast University Hospital
4215 Southport
AustraliaRekrutierend» Google-Maps
St Vincents Hospital Melbourne
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Peking University Peoples Hospital
100044 Beijing
ChinaRekrutierend» Google-Maps
The First Hospital of Lanzhou University
730000 Lanzhou
ChinaRekrutierend» Google-Maps
Guangdong Provincial Peoples Hospital
510080 Guangzhou
ChinaRekrutierend» Google-Maps
Nanfang Hospital of Southern Medical University
510515 Guangzhou
ChinaRekrutierend» Google-Maps
The Second Peoples Hospital of Shenzhen
518037 Shenzhen
ChinaRekrutierend» Google-Maps
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
430022 Wuhan
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Soochow University
215006 Suzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University Branch Donghu
330006 Nanchang
ChinaRekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
Tianjin Medical University Cancer Institute and Hospital
300060 Tianjin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University School of Medicine
310003 Hangzhou
ChinaRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Wellington Regional Hospital (Ccdhb)
6021 Wellington
New ZealandRekrutierend» Google-Maps
Hospital de La Santa Creu I Sant Pau
08025 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitari I Politecnic La Fe
46026 Valencia
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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) .

Ein-/Ausschlusskriterien

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. 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.

Studien-Rationale

Primary outcome:

1. Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) (Time Frame - Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs))

2. Part 1 And 2: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing Treatment-emergent Adverse Events (TEAEs) (Time Frame - Approximately 24 months)

3. Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate (Time Frame - Approximately 24 months):
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.

4. Part 3 MDS Cohort: Modified Overall Response (mOR) Rate (Time Frame - Approximately 24 months):
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).

5. 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 (Time Frame - Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose))

6. Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Coadministered With Posaconazole (Time Frame - Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose))

7. 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 (Time Frame - Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose))

8. Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs (Time Frame - Cycle 2)

9. Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs (Time Frame - Approximately 24 months)

Secondary outcome:

1. Parts 1 And 2 AML Cohort: CR Plus CRh Rate (Time Frame - Approximately 24 months)

2. Parts 1 And 2 MDS Cohort: mOR Rate (Time Frame - Approximately 24 months)

3. Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

4. Parts 1 And 2: t1/2 Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

5. Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

6. Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

7. Parts 1 And 2: Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

8. Parts 1 And 2: Apparent Volume Of Distribution (Vz/F) Of Azacitidine When Coadministered With BGB-11417 (Time Frame - Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose)

9. 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 (Time Frame - Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose)

10. Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine (Time Frame - Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose)

11. Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine (Time Frame - Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose)

12. Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine (Time Frame - Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose)

13. Part 3: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing TEAEs (Time Frame - Approximately 24 months)

14. Part 3: Complete Response (Time Frame - Approximately 24 months):
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.

15. Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate (Time Frame - Approximately 24 months):
CRi will be defined as the proportion of participants whose BOR is CRi.

16. Part 3 AML Cohort: Overall Response Rate (ORR) (Time Frame - Approximately 24 months):
The ORR will include participants whose BOR include CR, CRi, PR, and morphologic leukemia-free state.

17. Part 3 AML Cohort: Duration Of Response (DOR) (Time Frame - Approximately 24 months):
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.

18. Part 3 AML Cohort: Time To Response (TTR) (Time Frame - Approximately 24 months):
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.

19. Part 3 AML Cohort: Event-free Survival (EFS) (Time Frame - Approximately 24 months):
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.

20. Part 3 AML Cohort: Overall Survival (OS) (Time Frame - Approximately 24 months):
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.

21. Part 3 AML Cohort: Number Of Participants Receiving BGB-11417 In Combination With Posaconazole Experiencing TEAEs (Time Frame - Approximately 24 months)

22. Part 3 AML Cohort: Number of Participants with Transfusion Independence (Time Frame - Approximately 24 months):
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.

23. Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E) (Time Frame - Approximately 24 months):
The proportion of participants whose BOR is HI-E

24. Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P) (Time Frame - Approximately 24 months):
The proportion of participants whose BOR is HI-P

25. Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N) (Time Frame - Approximately 24 months):
The proportion of participants whose BOR is HI-N will be reported.

26. Part 3 MDS Cohort: Number of participants with Transfusion Independence (Time Frame - Approximately 24 months):
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.

27. Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine (Time Frame - Cycle 1 Day 1 and Cycle 2 Day 5 (predose and 4 and 6 hours postdose))

28. Part 3 MDS cohort: Partial Hematologic Recovery CRh (Time Frame - Approximately 24 months):
Proportion of participants with partial hematologic recovery will be reported

29. Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery (Time Frame - Approximately 24 months):
Proportion of participants with Complete Response + Morphologic complete Remission with Partial Hematologic Recovery will be reported.

30. Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417 (Time Frame - Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose))

31. Part 3 MDS (Treated with Monotherapy): Modified Overall Response (Time Frame - Approximately 24 months):
Proportion of participants with modified overall response including CR, marrow CR (mCR) or partial remission (PR)

32. Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417 (Time Frame - Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose))

Studien-Arme

  • 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.

Geprüfte Regime

  • BGB-11417 (Sonrotoclax):
    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 or 21 days on a 28-day

Quelle: ClinicalTrials.gov


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