The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Debio 1347 oral tablets.
Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria
ORR was defined as the percentage of participants with a best overall response (BOR) of partial or complete response (PR or CR). BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to disease progression or end of study (up to 1 year and 9 months)
Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)
DOR was defined as the time from the date of the initial PR or CR to date of the first documented progression or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to disease progression or end of study (up to 2 years and 9 months)
Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC)
DCR was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or stable disease (SD) ≥6 weeks. BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
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Ironwood Cancer & Research Centers - Scottsdale
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Tulane University Cancer Center
New Orleans, Louisiana, United States
The John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
...and 95 more locations
Time frame: Up to disease progression or end of study (up to 2 years and 9 months)
Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC)
PFS was defined as the time from the start date of treatment to date of the first documented progression or death due to any cause.
Time frame: From the start of the study up to disease progression or death (up to 2 years and 9 months)
Overall Survival (OS)
OS was defined as the time from the start date of treatment to date of death due to any cause. Participants with no documented death were censored at the last date known to be alive.
Time frame: Until death or loss to follow-up or end of study (up to 2 years and 9 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v5.0 and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that either starts or worsens in severity on or after the first administration of the study drug and within 30 days of the last administration of the study drug. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)
Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma
Geometric mean and geometric percent CV summary was estimated based on log-linear model.
Time frame: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma
Geometric mean and geometric percent CV summary was estimated based on log-linear model.
Time frame: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Time frame: Pre-dose on Days 14 and 28, and 1, 3, 7 hours post-dose on Day 28 of Cycle 1; pre-dose on Days 14 and 28, and 3 hours post-dose on Day 28 of Cycle 2 (each cycle length = 28 days)