This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
359
Unesbulin will be administered as per the dose and schedule specified in the arm description.
Dacarbazine will be administered as per the dose and schedule specified in the arm description.
Placebo will be administered as per the schedule specified in the arm description.
Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
PFS was defined as the time from randomization to the documented disease progression or death due to any cause, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression.
Time frame: Up to approximately 2 years
Overall Survival
Overall survival was defined as the time in months from the randomization date to the date of death from any cause or date last known alive for those who did not die.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1
ORR was defined as percentage of participants who achieved a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1
DCR was defined as percentage of participants who achieved a confirmed BOR of CR, PR, or at least 3 months of stable disease (SD). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
Stanford Cancer Center
Stanford, California, United States
University of Colorado Denver
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Florida (UF) Health Cancer Center - Orlando Health
Orlando, Florida, United States
Moffitt
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
...and 44 more locations
Time frame: Up to approximately 2 years
Duration of Response Per Independent Central Review Using RECIST V1.1
Duration of response was defined as the time from the date of first confirmed response of CR or PR to the date of the first documented disease progression or death due to any cause, whichever occurred first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time frame: Up to approximately 2 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A TEAE was defined as an AE that had an onset date on or after the first dose of study drug until 30 days after last dose or occurred prior to first dose of study drug and worsened in severity after first dose of study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time frame: From first dose of study drug up to approximately 2 years