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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03834220
Registration number
NCT03834220
Ethics application status
Date submitted
4/02/2019
Date registered
7/02/2019
Date last updated
7/02/2024
Titles & IDs
Public title
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
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Scientific title
A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3
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Secondary ID [1]
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2018-003584-53
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Secondary ID [2]
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Debio 1347-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Debio 1347
Experimental: Cohort 1: Debio 1347 (Biliary Tract Cancer) - Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 milligrams (mg) tablets, orally, once daily (QD), from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks).
Experimental: Cohort 2: Debio 1347 (Urothelial Cancer) - Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks).
Experimental: Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) - Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks).
Treatment: Drugs: Debio 1347
Debio 1347 oral tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria
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Assessment method [1]
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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.
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Timepoint [1]
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Up to disease progression or end of study (up to 1 year and 9 months)
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Secondary outcome [1]
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Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to disease progression or end of study (up to 2 years and 9 months)
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Secondary outcome [2]
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Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC)
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Assessment method [2]
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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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Timepoint [2]
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Up to disease progression or end of study (up to 2 years and 9 months)
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Secondary outcome [3]
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Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC)
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Assessment method [3]
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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.
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Timepoint [3]
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From the start of the study up to disease progression or death (up to 2 years and 9 months)
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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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.
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Timepoint [4]
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Until death or loss to follow-up or end of study (up to 2 years and 9 months)
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Secondary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)
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Secondary outcome [6]
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Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma
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Assessment method [6]
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Geometric mean and geometric percent CV summary was estimated based on log-linear model.
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Timepoint [6]
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Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
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Secondary outcome [7]
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Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma
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Assessment method [7]
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Geometric mean and geometric percent CV summary was estimated based on log-linear model.
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Timepoint [7]
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Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
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Secondary outcome [8]
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Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
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Assessment method [8]
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Timepoint [8]
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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)
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Eligibility
Key inclusion criteria
- Cytologically or histologically confirmed advanced solid tumor
- Radiographic progression on prior systemic therapy; prior localized therapy (i.e.,
radiation, ablation, embolization) is allowed provided radiographic progression
out-of-field or in the treatment, field is shown
- Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene
fusion/rearrangement potentially leading to a functional FGFR aberrant protein,
identified through local and/or central molecular assay
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of hypersensitivity to any of the excipients in the Debio 1347 formulation
- History and/or current evidence of ectopic mineralization/calcification, including but
not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon
calcifications
- Administration of any investigational agent within 2 weeks prior to initial dosing
with Debio 1347 (3 weeks for immune checkpoint inhibitors)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Recruitment
Recruitment status
Terminated
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/01/2022
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Sample size
Target
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Accrual to date
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Final
63
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Recruitment in Australia
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Southern Highlands Private Hospital - Bowral
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Peninsula and Southeast Oncology (PASO) - Frankston
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Linear Clinical Research, B Block Sir Charles Gairdner Hospital - Nedlands
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John Flynn Private Hospital - Tugun
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NSW 2576 - Bowral
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3199 - Frankston
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6009 - Nedlands
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4224 - Tugun
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Debiopharm International SA
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Address
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Other
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Caris Life Sciences
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03834220
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03834220
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