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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
2018-003584-53
Secondary ID [2] 0 0
Debio 1347-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria
Timepoint [1] 0 0
Up to disease progression or end of study (up to 1 year and 9 months)
Secondary outcome [1] 0 0
Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)
Timepoint [1] 0 0
Up to disease progression or end of study (up to 2 years and 9 months)
Secondary outcome [2] 0 0
Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC)
Timepoint [2] 0 0
Up to disease progression or end of study (up to 2 years and 9 months)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC)
Timepoint [3] 0 0
From the start of the study up to disease progression or death (up to 2 years and 9 months)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Until death or loss to follow-up or end of study (up to 2 years and 9 months)
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)
Secondary outcome [6] 0 0
Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma
Timepoint [6] 0 0
Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Secondary outcome [7] 0 0
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma
Timepoint [7] 0 0
Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)
Secondary outcome [8] 0 0
Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Timepoint [8] 0 0
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2022
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [2] 0 0
Peninsula and Southeast Oncology (PASO) - Frankston
Recruitment hospital [3] 0 0
Linear Clinical Research, B Block Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 0 0
John Flynn Private Hospital - Tugun
Recruitment postcode(s) [1] 0 0
NSW 2576 - Bowral
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
4224 - Tugun
Recruitment outside Australia
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United States of America
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Arizona
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California
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Massachusetts
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Michigan
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Austria
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Salzburg
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Austria
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Ijuí
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Rio Grande
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Dobrich
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Plovdiv
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Sofia
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Varaždin
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Zagreb
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Brno
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Hradec Králové
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Olomouc
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Prague
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Praha
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Aalborg
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Ioánnina
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Gyeonggi-do
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Incheon
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Warszawa
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Timisoara
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Omsk
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Tomsk
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Madrid
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Taipei
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Taoyuan
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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United Kingdom
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Dundee
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Debiopharm International SA
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Caris Life Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Optimal Research (Just In Time sites)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03834220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03834220