AzTrials
AzTrials

Solid TumorPhase 2NCT03834220

Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

A Phase 2 study testing Debio 1347 in people with Solid Tumor, run by Debiopharm International SA at 105 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Debio 1347
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
105 sitesin 23 countries
Study dates
22 Mar 2019to 4 Jan 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

105 sites in 23 countries.

105 sites in 23 countries

United States25 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The John Hopkins Hospital

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • UC Health, LLC.

    Cincinnati, Ohio, 45229

  • The Ohio State University Wexner Medical Center - James Cancer Hospital

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Cancer Center

    Harrison, New York, 10604

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 10202

  • University of Wisconsin

    Madison, Wisconsin, 53706

  • Memorial Sloan Kettering Cancer Center

    Middletown, New Jersey, 07748

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Tulane University Cancer Center

    New Orleans, Louisiana, 70122

  • Memorial Sloan-Kettering Hospital

    New York, New York, 10065

  • West Penn - Allegheny Oncology Network

    Pittsburgh, Pennsylvania, 15224

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah, 84108

  • University of California San Francisco

    San Francisco, California, 94115

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Ironwood Cancer & Research Centers - Scottsdale

    Scottsdale, Arizona, 85260

  • Fred Hutchinson/Seattle Care Alliance

    Seattle, Washington, 98109

  • H. Lee Moffitt Cancer Center and Research Institute, Inc

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85721

  • CTCA Cancer Treatment Centers

    Tulsa, Oklahoma, 74133

Other trials in United States

Taiwan7 sites

  • Shuang Ho Hospital

    New Taipei City, 23561

  • Taichung Veterans General Hospital, The Radiation Oncology Department

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Medical University Hospital (TMUH)

    Taipei, 11031

  • Taipei Veterans General Hospital, Medical Science & Technology Building

    Taipei, 11217

  • Linkou Chang-Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

France6 sites

  • ICO - Site Paul Papin

    Angers, 49055

  • CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque

    Bordeaux, 33075

  • Centre Oscar Lambret

    Lille, 59020

  • Groupe Hospitalier Sud - Hôpital Haut Lévêque

    Pessac, 33604

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Russia6 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk, 163045

  • TSBHI "Altai Territorial oncological dispensary"

    Barnaul, 656049

  • LLC Evimed

    Chelyabinsk, 454048

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

  • Tomsk Research Instutite of Oncology

    Tomsk, 634028

Other trials in Russia

South Korea6 sites

  • Seoul National University Bundang Hospital, Department of Oncology Medical office

    Gyeonggi-do, 13605

  • The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F

    Gyeonggi-do

  • Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital

    Incheon, 21565

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital (SNUH)

    Seoul, 03080

  • Ajou University Hospital, CRC room, Clinical Trial Center

    Suwon, 16499

Other trials in South Korea

Czechia5 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Thomayerova nemocnice

    Prague, 14000

Other trials in Czechia

Australia4 sites

  • Southern Highlands Private Hospital

    Bowral, NSW 2576

  • Peninsula and Southeast Oncology (PASO)

    Frankston, 3199

  • Linear Clinical Research, B Block Sir Charles Gairdner Hospital

    Nedlands, 6009

  • John Flynn Private Hospital

    Tugun, 4224

Other trials in Australia

Brazil4 sites

  • Hospital de Caridade de Ijuí, Avenida David J Martins

    Ijuí, 98700-000

  • Hospital de Clínicas de Porto Alegre

    Rio Grande, 90035-903

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, 09060-870

  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo

    São Paulo, 01246-000

Other trials in Brazil

Greece4 sites

  • General Hospital of Athens Laiko

    Athens, 11527

  • General Hospital of Athens of Chest Diseases "SOTIRIA"

    Athens, 11527

  • General Hospital of Athens "Alexandra"

    Athens, 11528

  • University General Hospital of Ioannina

    Ioannina, 45500

Other trials in Greece

Romania4 sites

  • S.C Delta Health Care S.R.L

    Bucharest, 014142

  • S.C Medisprof S.R.L.

    Cluj-Napoca, 400641

  • S.C Centrul de Oncologie Sf. Nectarie S.R.L.

    Craiova, 200347

  • S.C Oncocenter Oncologie Clinica S.R.L.

    Timișoara, 300166

Other trials in Romania

United Kingdom4 sites

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Guy's Hospital

    London, SE1 9RY

  • Hammersmith Hospital

    London, W12 0HS

  • The Christie

    Manchester, M20 4BX

Other trials in United Kingdom

Bulgaria3 sites

  • MHAT - Dobrich

    Dobrich, 9300

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • MHAT "Serdika", EOOD

    Sofia, 1632

Other trials in Bulgaria

Denmark3 sites

  • Ålborg Universitets Hospital

    Aalborg, 9100

  • Herlev Hospital

    Herlev, 2730

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Philippines3 sites

  • Cebu Doctors' University Hospital (CDUH), Research Office

    Cebu City, 6000

  • Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory

    Ermita, 1000

  • St. Luke's Medical Center, Human Cancer Biobank Research Center

    Quezon City, 1112

Other trials in Philippines

Poland3 sites

  • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

    Poznan, 60-355

  • MTZ Clinical Research

    Warsaw, 02-106

  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

    Warsaw, 02-781

Other trials in Poland

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Ukraine3 sites

  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipro, 49102

  • SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery

    Kharkiv, 61018

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, 61070

Other trials in Ukraine

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Croatia2 sites

  • General Hospital Varazdin

    Varaždin, 42000

  • University Hospital Centre, Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Finland2 sites

  • Docrates Syöpäsairaala

    Helsinki, 00180

  • Helsinki University Hospital

    Helsinki, 00290

Other trials in Finland

Netherlands2 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Haga Ziekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Norway2 sites

  • Akershus University Hospital

    Lørenskog, 1478

  • Radiumhospitalet, Montebello

    Oslo, 0310

Other trials in Norway

Singapore2 sites

  • Singapore National Cancer Center (SNCC)

    Singapore, 169610

  • Tan Tock Seng Hospital, Communicable Disease Centre

    Singapore, 308440

Other trials in Singapore

About this study

Official 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

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.

Conditions
Solid Tumor
Being tested
Debio 1347

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Debio 1347Drug

    Debio 1347 oral tablets.

Study groups in NCT03834220
Study groupRoleWhat they receive
Cohort 1: Debio 1347 (Biliary Tract Cancer)ExperimentalParticipants 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).
Receives: Drug: Debio 1347
Cohort 2: Debio 1347 (Urothelial Cancer)ExperimentalParticipants 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).
Receives: Drug: Debio 1347
Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)ExperimentalParticipants 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).
Receives: Drug: Debio 1347

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to disease progression or end of study (up to 1 year and 9 months)

Secondary outcomes (8)

  1. 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.

    Measured: Up to disease progression or end of study (up to 2 years and 9 months)

  2. 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.

    Measured: Up to disease progression or end of study (up to 2 years and 9 months)

  3. 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.

    Measured: From the start of the study up to disease progression or death (up to 2 years and 9 months)

  4. 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.

    Measured: Until death or loss to follow-up or end of study (up to 2 years and 9 months)

  5. 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.

    Measured: From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months)

  6. 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.

    Measured: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)

  7. 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.

    Measured: Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days)

  8. Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start22 Mar 2019
  3. Primary completion31 Dec 2020
  4. Study completion4 Jan 2022

Why it stopped: Due to lower antitumor activity than expected

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834220
Sponsor's protocol ID
Debio 1347-201
Other IDs
2018-003584-53, 2018
Status last verified
Jan 2024
First submitted
4 Feb 2019
Last updated
7 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Debio 1347 in people with Solid Tumor, run by Debiopharm International SA at 105 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Taiwan, France, Russia, South Korea and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (time frame: Up to disease progression or end of study (up to 1 year and 9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in