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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

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
Country [1] 0 0
United States of America
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Arizona
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California
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Florida
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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New Jersey
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New York
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North Carolina
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Oklahoma
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Wisconsin
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Austria
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Salzburg
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Austria
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Wiener Neustadt
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Brazil
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Ijuí
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Brazil
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Rio Grande
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Brazil
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Santo André
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Brazil
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São Paulo
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Dobrich
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Plovdiv
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Sofia
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Croatia
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Varaždin
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Croatia
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Zagreb
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Czechia
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Brno
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Czechia
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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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Herlev
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Lille
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Athens
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Ioánnina
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Gyeonggi-do
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Incheon
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Lørenskog
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Oslo
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Ermita
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Quezon City
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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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Russian Federation
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Omsk
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Russian Federation
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Tomsk
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Singapore
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Singapore
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Spain
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Barcelona
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Madrid
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Valencia
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Taiwan
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New Taipei City
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Taichung
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Tainan
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Taipei
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Taiwan
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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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United Kingdom
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London
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United Kingdom
State/province [83] 0 0
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
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03834220