The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.
Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.
University of Arizona Cancer Center
Tucson, Arizona, United States
UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
Clinical Research Alliance
Lake Success, New York, United States
Number of treatment-emergent adverse events (TEAEs)
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.
Time frame: Up to approximately 6 months
Cmax of INCB053914 in combination with INCB050465
Maximum observed plasma concentration.
Time frame: Day 15
Tmax of INCB053914 in combination with INCB050465
Time to maximum plasma concentration.
Time frame: Day 15
Cmin of INCB053914 in combination with INCB050465
Minimum observed plasma concentration during the dosing interval.
Time frame: Day 15
AUC0-t of INCB053914 in combination with INCB050465
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
Time frame: Day 15
Cl/F of INCB053914 in combination with INCB050465
Oral dose clearance.
Time frame: Day 15
Overall response rate
Defined as the percentage of participants with a complete remission (CR)/complete metabolic response (CMR) or partial remission (PR)/partial metabolic response (PMR) as defined by investigator assessment per revised Lugano classification criteria for lymphomas.
Time frame: Up to approximately 6 months
Duration of response
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Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment.
Time frame: Up to approximately 6 months
Progression-free survival
Defined as the time from the date of the first dose of any study drug until the earliest date of disease progression, as determined by radiographic disease assessment, or death from any cause, whichever occurs first.
Time frame: Up to approximately 6 months