Study Stopped
As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
1 other identifier
interventional
69
1 country
12
Brief Summary
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2015
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
June 14, 2019
CompletedJune 14, 2019
May 1, 2019
2.8 years
April 27, 2015
January 29, 2019
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
up to 30 days
Secondary Outcomes (10)
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
Summary of steady-state PK parameters by dosing regimen at Day 15
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
Summary of steady-state PK parameters by dosing regimen at Day 15
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
Summary of steady-state PK parameters by dosing regimen at Day 15
AUC0-t Analysis of INCB054329
Summary of steady-state PK parameters by dosing regimen at Day 15
Cl/F Analysis of INCB054329
Summary of steady-state PK parameters by dosing regimen at Day 15
- +5 more secondary outcomes
Study Arms (1)
INCB054329 Monotherapy
EXPERIMENTALInterventions
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
You may qualify if:
- Confirmed diagnosis of advanced malignancy:
- 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
You may not qualify if:
- Inadequate hematopoietic, liver, endocrine or renal function
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, San Francisco, Medical Center at Mount Zion
San Francisco, California, 94115, United States
Sarah Cannon Research Institute Research Center
Denver, Colorado, 80218, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
John Hopkins
Baltimore, Maryland, 21287-0013, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0021, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Related Publications (1)
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.
PMID: 31527168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Fred Zheng, M.D.
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 27, 2015
First Posted
April 30, 2015
Study Start
April 14, 2015
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
June 14, 2019
Results First Posted
June 14, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share