This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Oral Tablet Formulation
Oral Tablet Formulation
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States
Incidence of Adverse Events (Escalation Phase)
Identify the observed adverse events and serious adverse events associated with inlexisertib in combination with other anticancer therapies.
Time frame: Approximately 24 months
Recommended Phase 2 Doses (RP2D) (Escalation Phase)
Identify the dose-limiting toxicities for each dose level tested and determine the recommended Phase 2 doses of inlexisertib in combination with other anticancer therapies.
Time frame: Approximately 18 months
Objective response rate (ORR) (Expansion Phase)
Proportion of participants who achieve CR or PR per histology-specific consensus response criteria.
Time frame: Approximately 24 months
Duration of response (DoR)
DoR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) per histology-specific consensus response criteria until the first date that the progressive disease is objectively documented or death, whichever occurs first.
Time frame: Approximately 24 months
Disease Control Rate (DCR)
The DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) per histology-specific consensus response criteria.
Time frame: Approximately 24 months
Time to response
Time to response is defined as the time from initiation of treatment until the first assessment demonstrating CR or PR per histology-specific consensus response criteria.
Time frame: Approximately 24 months
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Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGUniversity of Massachusetts Worcester
Worcester, Massachusetts, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGWashington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
RECRUITINGCleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITING...and 2 more locations
Progression-free survival (PFS)
PFS is defined as the time from initiation of treatment until documented disease progression per histology-specific consensus response criteria or death, whichever occurs first.
Time frame: Approximately 24 months
Overall Survival (OS)
OS is defined as the time from initiation of treatment until death.
Time frame: Approximately 48 months
Maximum observed concentration (Cmax)
Measure the maximum observed concentration of inlexisertib combinations.
Time frame: Predose and up to 12 hours postdose
Time to maximum observed concentration (Tmax)
Measure the time to maximum plasma concentration of inlexisertib combinations.
Time frame: Predose and up to 12 hours postdose
Minimum observed concentration (Cmin)
Measure the minimum observed concentration of inlexisertib combinations.
Time frame: Predose and up to 12 hours postdose
Area under the concentration-time curve (AUC)
Measure the AUC of inlexisertib combinations.
Time frame: Predose and up to 12 hours postdose