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Epigenetic Modifying Agent

BGB-11417 for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1 & 2

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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; Life expectancy of > 12 weeks; Ability to comply with the requirements of the study.

Confirmed diagnosis of one of the following by 2016 World Health Organization criteria: AML, nonacute promyelocytic leukemia; MDS; MDS/MPN; Eastern Cooperative Oncology Group performance status of 0 to 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

Study Summary

This trial will help find the best dose of the new drug BGB-11417 to treat people with acute myeloid leukemia or myelodysplastic syndrome, with or without myeloproliferative neoplasm.

Who is the study for?

This trial is for adults with certain blood disorders like AML, MDS, or MDS/MPN. They should be relatively active (able to care for themselves), have kidneys and liver working well, and expected to live more than 12 weeks. People can't join if they've had leukemia in the brain, certain other cancers in the last 2 years, specific blood diseases including myelofibrosis or polycythemia vera, or previous treatments with similar drugs.Check my eligibility

What is being tested?

The study tests BGB-11417 alone and combined with azacitidine to find a safe dose and see how effective it is against acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Posaconazole is also used as part of the treatment regimen.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, diarrhea; low blood cell counts leading to increased infection risk; fatigue; liver issues; kidney problems. The exact side effects will depend on individual reactions to BGB-11417 and azacitidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with AML, MDS, or MDS/MPN and can care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

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

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

+6 more

Secondary outcome measures

Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery

Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417

Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate

+29 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Parts 1 and 2: MDS CohortsExperimental Treatment2 Interventions

Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.

Group II: Parts 1 and 2: AML CohortsExperimental Treatment2 Interventions

Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.

Group III: Part 3: AML and MDS CohortsExperimental Treatment3 Interventions

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.

Group IV: Part 3: AML and MDS CohortExperimental Treatment1 Intervention

Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Posaconazole

2018

Completed Phase 4

~4080

Azacitidine

2012

Completed Phase 3

~1440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,554 Total Patients Enrolled

David Simpson, MDStudy DirectorBeiGene

4 Previous Clinical Trials

167 Total Patients Enrolled

Media Library

Azacitidine (Epigenetic Modifying Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04771130 — Phase 1 & 2

Acute Myeloid Leukemia Research Study Groups: Part 3: AML and MDS Cohort, Parts 1 and 2: AML Cohorts, Parts 1 and 2: MDS Cohorts, Part 3: AML and MDS Cohorts

Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04771130 — Phase 1 & 2

Azacitidine (Epigenetic Modifying Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04771130 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions does BGB-11417 commonly address?

"BGB-11417 is generally prescribed for purposes related to complete blood count. Other uses include the treatment of refractory anemias, induction chemotherapy, and acute myelocytic leukemia."

Answered by AI

Have any prior investigations included BGB-11417?

"At this moment, 182 medical trials are researching the efficacy of BGB-11417. 34 of these ongoing studies is in phase 3 and most occur in Saint Louis, Missouri; however, there a plethora of 5757 other locations conducting research for this potential treatment."

Answered by AI

What is the quota of participants selected to this trial?

"Affirmative, clinicaltrials.gov affirms that this research is actively enrolling participants. Initially posted on May 24th 2021 and last updated on August 18th 2022, the study hopes to recruit 260 patients from a single site."

Answered by AI

Are new participants being accepted for this clinical trial?

"The clinical trial is still in search of participants, as per the information on clinicaltrials.gov; it was initially posted on May 24th 2021 and its details were updated most recently on August 18th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BGB-11417 in Participants With Myeloid Malignancies

2021. "A Study of BGB-11417 in Participants With Myeloid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04771130.

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