A Study of BGB-11417 in Participants With Myeloid Malignancies

Study Purpose

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) .

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04771130
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	BeiGene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, China, Germany, Korea, Republic of, New Zealand, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm

Arms & Interventions

Arms

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.

Interventions

Drug: - BGB-11417

Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.

Drug: - Azacitidine

Intravenous or subcutaneous administration for 7 days.

Drug: - Posaconazole

Oral administration for 8 days on second cycle only.

Drug: - BGB-11417

Oral administration for 28 days on a 28-day cycle.

Drug: - BGB-11417

Oral administration for 10 or 21 days on a 28-day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope National Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope National Medical Center

Duarte, California, 91010

Site Contact

MPN Clinical Trial Finder

Clinical Trial Finder