The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Film-coated tablet
Objective Response (OR) per RECIST 1.1
Time frame: Up to 35 months
Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Time frame: Up to 35 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 35 months
Number of Participants Experiencing Events of Interest (EOIs)
Time frame: Up to 35 months
Maximum Concentration (Cmax) of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Time to Cmax (Tmax) of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Area Under The Concentration-time Curve (AUC) of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Disease Control (DC) by BICR
Time frame: Up to 35 months
Duration of Response (DOR) by BICR
Time frame: Up to 35 months
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City of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
RECRUITINGRocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITINGEastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
RECRUITINGHartford HealthCare Cancer Institute - Manchester
Plainville, Connecticut, United States
RECRUITINGMedstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGOur Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
RECRUITING...and 81 more locations
Time to Response (TTR) by BICR
Time frame: Up to 35 months
Progression-free Survival (PFS) by BICR
Time frame: Up to 35 months
OR by Investigator's Assessment
Time frame: Up to 35 months
DC by Investigator's Assessment
Time frame: Up to 35 months
DOR by Investigator's Assessment
Time frame: Up to 35 months
TTR by Investigator's Assessment
Time frame: Up to 35 months
PFS by Investigator's Assessment
Time frame: Up to 35 months
Overall Survival (OS)
Time frame: Up to 35 months
Number of Participants Experiencing TEAEs
Time frame: Up to 35 months
Cmax of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Tmax of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
AUC of anvumetostat
Time frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30
Time frame: Up to 12 months
Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)
Time frame: Up to 12 months
Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Up to 12 months
Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to 12 months
Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Up to 12 months