An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
NCT ID: NCT02431260
Last Updated: 2019-06-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
69 participants
INTERVENTIONAL
2015-04-14
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose-escalation Study in Subjects With Advanced Malignancies
NCT01195311
A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies
NCT03522142
A Dose-escalation Study in Subjects With Advanced Malignancies
NCT01072266
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
NCT04272034
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
NCT00820560
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
INCB054329 Monotherapy
INCB054329 Monotherapy
Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INCB054329 Monotherapy
Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
* Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia \[AML\] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
* Treatment Group C (TGC): Multiple myeloma
* Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion
Exclusion Criteria
* Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
* \< 6 weeks for mitomycin-C or nitrosoureas
* \< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)
* \< 28 days for any antibodies or biological therapies
* \< 5 half-lives for all other anticancer medications, or sponsor approval
* Prior radiotherapy within 2 weeks prior to first dose of study drug
* Untreated brain or central nervous system (CNS) metastases
* Type 1 diabetes or uncontrolled Type 2 diabetes
* Any sign of clinically significant bleeding
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fred Zheng, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco, Medical Center at Mount Zion
San Francisco, California, United States
Sarah Cannon Research Institute Research Center
Denver, Colorado, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Horizon Oncology Center
Lafayette, Indiana, United States
John Hopkins
Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INCB 54329-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.