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

NCT03834220 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: Debio 1347-2012018-003584-53
• Study Type: interventional
• Target: 63
• Locations: 22 countries
• Sites: 103

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC)

  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)

  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)

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

• Overall Survival (OS)

  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)

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

Study Arms (3)

Cohort 1: Debio 1347 (Biliary Tract Cancer)

EXPERIMENTAL

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).

Drug: Debio 1347

Cohort 2: Debio 1347 (Urothelial Cancer)

EXPERIMENTAL

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).

Drug: Debio 1347

Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)

EXPERIMENTAL

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).

Drug: Debio 1347

Interventions

Debio 1347 DRUG

Debio 1347 oral tablets.

Cohort 1: Debio 1347 (Biliary Tract Cancer); Cohort 2: Debio 1347 (Urothelial Cancer); Cohort 3: Debio 1347 (All Other Solid Tumor Histologies)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Debiopharm International SA: lead
• Caris Life Sciences: collaborator
• Optimal Research (Just In Time sites): collaborator

Study Sites (105)

Ironwood Cancer & Research Centers - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85721, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

H. Lee Moffitt Cancer Center and Research Institute, Inc

Tampa, Florida, 33612, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 10202, United States

Location

Tulane University Cancer Center

New Orleans, Louisiana, 70122, United States

Location

The John Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, 07748, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Memorial Sloan Kettering Cancer Center

Harrison, New York, 10604, United States

Location

Memorial Sloan-Kettering Hospital

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UC Health, LLC.

Cincinnati, Ohio, 45229, United States

Location

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

CTCA Cancer Treatment Centers

Tulsa, Oklahoma, 74133, United States

Location

West Penn - Allegheny Oncology Network

Pittsburgh, Pennsylvania, 15224, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah Hospitals & Clinics

Salt Lake City, Utah, 84108, United States

Location

Fred Hutchinson/Seattle Care Alliance

Seattle, Washington, 98109, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Southern Highlands Private Hospital

Bowral, NSW 2576, Australia

Location

Peninsula and Southeast Oncology (PASO)

Frankston, 3199, Australia

Location

Linear Clinical Research, B Block Sir Charles Gairdner Hospital

Nedlands, 6009, Australia

Location

John Flynn Private Hospital

Tugun, 4224, Australia

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Hospital de Caridade de Ijuí, Avenida David J Martins

Ijuí, 98700-000, Brazil

Location

Hospital de Clínicas de Porto Alegre

Rio Grande, 90035-903, Brazil

Location

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, 09060-870, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

MHAT - Dobrich

Dobrich, 9300, Bulgaria

Location

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, 4004, Bulgaria

Location

MHAT "Serdika", EOOD

Sofia, 1632, Bulgaria

Location

General Hospital Varazdin

Varaždin, 42000, Croatia

Location

University Hospital Centre, Sestre Milosrdnice

Zagreb, 10000, Croatia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Thomayerova nemocnice

Prague, 14000, Czechia

Location

Ålborg Universitets Hospital

Aalborg, 9100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Docrates Syöpäsairaala

Helsinki, 00180, Finland

Location

Helsinki University Hospital

Helsinki, 00290, Finland

Location

ICO - Site Paul Papin

Angers, 49055, France

Location

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

Bordeaux, 33075, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Groupe Hospitalier Sud - Hôpital Haut Lévêque

Pessac, 33604, France

Location

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

General Hospital of Athens Laiko

Athens, 11527, Greece

Location

General Hospital of Athens of Chest Diseases "SOTIRIA"

Athens, 11527, Greece

Location

General Hospital of Athens "Alexandra"

Athens, 11528, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Haga Ziekenhuis

The Hague, 2545 AA, Netherlands

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Radiumhospitalet, Montebello

Oslo, 0310, Norway

Location

Cebu Doctors' University Hospital (CDUH), Research Office

Cebu City, 6000, Philippines

Location

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

Ermita, 1000, Philippines

Location

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

Quezon City, 1112, Philippines

Location

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

Poznan, 60-355, Poland

Location

MTZ Clinical Research

Warsaw, 02-106, Poland

Location

Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

Warsaw, 02-781, Poland

Location

S.C Delta Health Care S.R.L

Bucharest, 014142, Romania

Location

S.C Medisprof S.R.L.

Cluj-Napoca, 400641, Romania

Location

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

Craiova, 200347, Romania

Location

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

Timișoara, 300166, Romania

Location

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, 163045, Russia

Location

TSBHI "Altai Territorial oncological dispensary"

Barnaul, 656049, Russia

Location

LLC Evimed

Chelyabinsk, 454048, Russia

Location

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

Moscow, 115478, Russia

Location

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, 644013, Russia

Location

Tomsk Research Instutite of Oncology

Tomsk, 634028, Russia

Location

Singapore National Cancer Center (SNCC)

Singapore, 169610, Singapore

Location

Tan Tock Seng Hospital, Communicable Disease Centre

Singapore, 308440, Singapore

Location

Seoul National University Bundang Hospital, Department of Oncology Medical office

Gyeonggi-do, 13605, South Korea

Location

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

Gyeonggi-do, South Korea

Location

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

Incheon, 21565, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital (SNUH)

Seoul, 03080, South Korea

Location

Ajou University Hospital, CRC room, Clinical Trial Center

Suwon, 16499, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Taichung Veterans General Hospital, The Radiation Oncology Department

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Medical University Hospital (TMUH)

Taipei, 11031, Taiwan

Location

Taipei Veterans General Hospital, Medical Science & Technology Building

Taipei, 11217, Taiwan

Location

Linkou Chang-Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

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

Dnipro, 49102, Ukraine

Location

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

Kharkiv, 61018, Ukraine

Location

Communal Non-profit Enterprise Regional Center of Oncology

Kharkiv, 61070, Ukraine

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Guy's Hospital

London, SE1 9RY, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

The Christie

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

CH5183284

Limitations and Caveats

Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data. Due to the premature termination of participant recruitment and shortened follow-up, the primary efficacy analysis was likely underpowered in the final analysis, leading to greater statistical uncertainty in results.

Results Point of Contact

• Title: Head Clinical Research & Development
• Organization: Debiopharm International S.A.

info-international@debiopharm.com

4121 321 01 11

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: March 22, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 4, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7); KR (6); GB (4); FI (2); UA (3); AU (4); GR (4); ES (3); NL (2); BR (4); CR (2); CZ (5); US (25); BU (3); DK (3); FR (6); NO (2); RO (4); PH (3); RU (6); PL (3); SG (2)