A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
Who is this study for? Patients with myeloid malignancies
What treatments are being studied? BGB-11417
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• 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.
Locations
United States
California
City of Hope National Medical Center
COMPLETED
Duarte
Florida
Tampa General Hospital
RECRUITING
Tampa
Pennsylvania
Upmc Hillman Cancer Center(Univ of Pittsburgh)
RECRUITING
Pittsburgh
Texas
Md Anderson Cancer Center
RECRUITING
Houston
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Monash Health
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Austin Health
RECRUITING
Heidelberg
St George Hospital
RECRUITING
Kogarah
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Linear Clinical Research
RECRUITING
Nedlands
One Clinical Research
RECRUITING
Nedlands
Orange Health Hospital
RECRUITING
Orange
Gold Coast University Hospital
RECRUITING
Southport
China
Peking University Peoples Hospital
RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
Guangdong Provincial Peoples Hospital
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University Branch Donghu
RECRUITING
Nanchang
The Second Peoples Hospital of Shenzhen
COMPLETED
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Tianjin Medical University Cancer Institute and Hospital
COMPLETED
Tianjin
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Hopital Claude Huriez Chu Lille
RECRUITING
Lille
Hopital Larchet
RECRUITING
Nice
Hopital Saint Louis
RECRUITING
Paris
Germany
Universitaetsklinikum Leipzig Aor
RECRUITING
Leipzig
Universitaetsklinikum Ulm
RECRUITING
Ulm
Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
RECRUITING
Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
RECRUITING
Meldola
Niguarda Cancer Center Division of Hematology
RECRUITING
Milan
New Zealand
Aotearoa Clinical Trials
ACTIVE_NOT_RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
Wellington Regional Hospital (Ccdhb)
RECRUITING
Wellington
Republic of Korea
Samsung Medical Center
RECRUITING
Gangnamgu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Spain
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari I Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Edinburgh Cancer Centre
RECRUITING
Edinburgh
The Christie Hospital
RECRUITING
Greater Manchester
Contact Information
Primary
BeiGene
clinicaltrials@beigene.com
1.877.828.5568
Time Frame
Start Date: 2021-05-24
Estimated Completion Date: 2028-02-08
Participants
Target number of participants: 260
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: BeiGene