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

Sponsor
Debiopharm International SA (Industry)
Overall Status
Terminated
CT.gov ID
NCT03834220
Collaborator
Caris Life Sciences (Other), Optimal Research (Just In Time sites) (Other)
63
105
1
33.5
0.6
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Debio 1347
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 22, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jan 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Debio 1347

Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.

Drug: Debio 1347
80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate (ORR) [Up to 44 months]

Secondary Outcome Measures

  1. Duration of Response (DOR) [Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)]

  2. Disease Control Rate (DCR) [Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)]

  3. Progression-Free Survival (PFS) [Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)]

  4. Overall Survival (OS) [Up to 44 months]

  5. Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to 44 months]

  6. Trough Concentration (Ctrough) of Debio 1347 [Up to Cycle 2 (each cycle is 28 days)]

  7. Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCt) of Debio 1347 [Up to Cycle 2 (each cycle is 28 days)]

  8. Correlation of Debio 1347 plasma concentration and QTcF [Up to 44 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ironwood Cancer & Research Centers - Scottsdale Scottsdale Arizona United States 85260
2 University of Arizona Cancer Center Tucson Arizona United States 85721
3 Moores UCSD Cancer Center La Jolla California United States 92093
4 University of California San Francisco San Francisco California United States 94115
5 Sarcoma Oncology Center Santa Monica California United States 90403
6 H. Lee Moffitt Cancer Center and Research Institute, Inc Tampa Florida United States 33612
7 James Graham Brown Cancer Center Louisville Kentucky United States 10202
8 Tulane University Cancer Center New Orleans Louisiana United States 70122
9 The John Hopkins Hospital Baltimore Maryland United States 21231
10 Massachusetts General Hospital Boston Massachusetts United States 02114
11 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
12 University of Michigan Ann Arbor Michigan United States 48109
13 Memorial Sloan Kettering Cancer Center Middletown New Jersey United States 07748
14 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
15 Memorial Sloan Kettering Cancer Center Harrison New York United States 10604
16 Memorial Sloan-Kettering Hospital New York New York United States 10065
17 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
18 UC Health, LLC. Cincinnati Ohio United States 45229
19 The Ohio State University Wexner Medical Center - James Cancer Hospital Columbus Ohio United States 43210
20 CTCA Cancer Treatment Centers Tulsa Oklahoma United States 74133
21 West Penn - Allegheny Oncology Network Pittsburgh Pennsylvania United States 15224
22 MD Anderson Cancer Center Houston Texas United States 77030
23 University of Utah Hospitals & Clinics Salt Lake City Utah United States 84108
24 Fred Hutchinson/Seattle Care Alliance Seattle Washington United States 98109
25 University of Wisconsin Madison Wisconsin United States 53706
26 Southern Highlands Private Hospital Bowral Australia NSW 2576
27 Peninsula and Southeast Oncology (PASO) Frankston Australia 3199
28 Linear Clinical Research, B Block Sir Charles Gairdner Hospital Nedlands Australia 6009
29 John Flynn Private Hospital Tugun Australia 4224
30 LKH - Universitätsklinikum der PMU Salzburg Salzburg Austria 5020
31 Landesklinikum Wiener Neustadt Wiener Neustadt Austria 2700
32 Hospital de Caridade de Ijuí, Avenida David J Martins Ijuí Brazil 98700-000
33 Hospital de Clínicas de Porto Alegre Rio Grande Brazil 90035-903
34 CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André Brazil 09060-870
35 ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo São Paulo Brazil 01246-000
36 MHAT - Dobrich Dobrich Bulgaria 9300
37 Complex Oncological Center - Plovdiv, EOOD Plovdiv Bulgaria 4004
38 MHAT "Serdika", EOOD Sofia Bulgaria 1632
39 General Hospital Varazdin Varaždin Croatia 42000
40 University Hospital Centre, Sestre Milosrdnice Zagreb Croatia 10000
41 Fakultni nemocnice u sv. Anny v Brne Brno Czechia 656 91
42 Fakultni nemocnice Hradec Kralove Hradec Králové Czechia 50005
43 Fakultni nemocnice Olomouc Olomouc Czechia 775 20
44 Thomayerova nemocnice Prague Czechia 14000
45 Fakultni nemocnice Kralovske Vinohrady Praha Czechia 100 34
46 Ålborg Universitets Hospital Aalborg Denmark 9100
47 Herlev Hospital Herlev Denmark 2730
48 Odense Universitetshospital Odense Denmark 5000
49 Docrates Syöpäsairaala Helsinki Finland 00180
50 Helsinki University Hospital Helsinki Finland 00290
51 ICO - Site Paul Papin Angers France 49055
52 CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque Bordeaux France 33075
53 Centre Oscar Lambret Lille France 59020
54 Groupe Hospitalier Sud - Hôpital Haut Lévêque Pessac France 33604
55 ICO - Site René Gauducheau Saint-Herblain France 44805
56 Institut Gustave Roussy Villejuif France 94805
57 General Hospital of Athens Laiko Athens Greece 11527
58 General Hospital of Athens of Chest Diseases "SOTIRIA" Athens Greece 11527
59 General Hospital of Athens "Alexandra" Athens Greece 11528
60 University General Hospital of Ioannina Ioánnina Greece 45500
61 Seoul National University Bundang Hospital, Department of Oncology Medical office Gyeonggi-do Korea, Republic of 13605
62 The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F Gyeonggi-do Korea, Republic of
63 Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital Incheon Korea, Republic of 21565
64 Korea University Anam Hospital Seoul Korea, Republic of 02841
65 Seoul National University Hospital (SNUH) Seoul Korea, Republic of 03080
66 Ajou University Hospital, CRC room, Clinical Trial Center Suwon Korea, Republic of 16499
67 VU Medisch Centrum Amsterdam Netherlands 1081 HV
68 Haga Ziekenhuis Den Haag Netherlands 2545 AA
69 Akershus University Hospital Lørenskog Norway 1478
70 Radiumhospitalet, Montebello Oslo Norway 0310
71 Cebu Doctors' University Hospital (CDUH), Research Office Cebu City Philippines 6000
72 Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory Ermita Philippines 1000
73 St. Luke's Medical Center, Human Cancer Biobank Research Center Quezon City Philippines 1112
74 Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu Poznań Poland 60-355
75 MTZ Clinical Research Warszawa Poland 02-106
76 Centrum Onkologii-Instytut im.M.Sklodowskiej Curie Warszawa Poland 02-781
77 S.C Delta Health Care S.R.L Bucuresti Romania 014142
78 S.C Medisprof S.R.L. Cluj-Napoca Romania 400641
79 S.C Centrul de Oncologie Sf. Nectarie S.R.L. Craiova Romania 200347
80 S.C Oncocenter Oncologie Clinica S.R.L. Timişoara Romania 300166
81 SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" Arkhangel'sk Russian Federation 163045
82 TSBHI "Altai Territorial oncological dispensary" Barnaul Russian Federation 656049
83 LLC Evimed Chelyabinsk Russian Federation 454048
84 FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" Moscow Russian Federation 115478
85 BHI of Omsk region "Clinical Oncology Dispensary" Omsk Russian Federation 644013
86 Tomsk Research Instutite of Oncology Tomsk Russian Federation 634028
87 Singapore National Cancer Center (SNCC) Singapore Singapore 169610
88 Tan Tock Seng Hospital, Communicable Disease Centre Singapore Singapore 308440
89 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
90 Centro Integral Oncologico Clara Campal Madrid Spain 28050
91 Hospital Clinico Universitario de Valencia Valencia Spain 46010
92 Shuang Ho Hospital New Taipei City Taiwan 23561
93 Taichung Veterans General Hospital, The Radiation Oncology Department Taichung Taiwan 40705
94 National Cheng Kung University Hospital Tainan Taiwan 704
95 National Taiwan University Hospital Taipei Taiwan 10048
96 Taipei Medical University Hospital (TMUH) Taipei Taiwan 11031
97 Taipei Veterans General Hospital, Medical Science & Technology Building Taipei Taiwan 11217
98 Linkou Chang-Gung Memorial Hospital Taoyuan Taiwan 33305
99 CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Dnipro Ukraine 49102
100 SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery Kharkiv Ukraine 61018
101 Communal Non-profit Enterprise Regional Center of Oncology Kharkiv Ukraine 61070
102 Ninewells Hospital Dundee United Kingdom DD1 9SY
103 Guy's Hospital London United Kingdom SE1 9RY
104 Hammersmith Hospital London United Kingdom W12 0HS
105 The Christie Manchester United Kingdom M20 4BX

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT03834220
Other Study ID Numbers:
  • Debio 1347-201
  • 2018-003584-53
First Posted:
Feb 7, 2019
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022