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).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
69
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
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
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.
Time frame: up to 30 days
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Time frame: Summary of steady-state PK parameters by dosing regimen at Day 15
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Time frame: Summary of steady-state PK parameters by dosing regimen at Day 15
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Time frame: Summary of steady-state PK parameters by dosing regimen at Day 15
AUC0-t Analysis of INCB054329
AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Time frame: Summary of steady-state PK parameters by dosing regimen at Day 15
Cl/F Analysis of INCB054329
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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
...and 2 more locations
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Time frame: Summary of steady-state PK parameters by dosing regimen at Day 15
Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data. The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined. Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
Time frame: Day 15 in all cohorts
Objective Response Rate (ORR)
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
Time frame: Baseline through end of study, up to 6 months
Duration of Response (DOR)
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
Time frame: Baseline through end of study, up to 6 months
Progression Free Survival (PFS)
PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first
Time frame: Baseline through end of study, up to 6 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of the participant's death.
Time frame: Baseline through end of study, up to 6 months for participants in Part 2