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FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05052801
Collaborator
(none)
516
Enrollment
141
Locations
2
Arms
33.9
Anticipated Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
516 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bemarituzumab with mFOLFOX6

Drug: Bemarituzumab
Intravenous (IV) infusion

Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Active Comparator: Placebo with mFOLFOX6

Drug: mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Drug: Placebo
IV infusion

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [Up to approximately 3.5 years]

Secondary Outcome Measures

  1. Progression-free Survival (PFS) [Up to approximately 3.5 years]

  2. Objective Response Rate (ORR) [Up to approximately 3.5 years]

  3. Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) [Up to approximately 3.5 years]

  4. Duration of Response (DOR) [Up to approximately 3.5 years]

  5. Disease Control Rate [Up to approximately 3.5 years]

  6. Mean Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [Up to approximately 3.5 years]

  7. Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [Baseline up to approximately 3.5 years]

  8. Stomach Cancer Related Symptom Mean Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [Up to approximately 3.5 years]

  9. Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [Baseline up to approximately 3.5 years]

  10. Mean Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [Up to approximately 3.5 years]

  11. Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) [Baseline up to approximately 3.5 years]

  12. Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) [Up to approximately 3.5 years]

  13. Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score [Up to approximately 3.5 years]

  14. Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score [Up to approximately 3.5 years]

  15. Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [Day 1 up to approximately 3.5 years]

  16. Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [Day 1 up to approximately 3.5 years]

  17. Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma [Day 1 up to approximately 3.5 years]

  18. Number of Participants with an Anti-bemarituzumab Antibody Formation [Day 1 up to approximately 3.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy

  • Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy

  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 1

  • Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1

  • Participant has no contraindications to mFOLFOX6 chemotherapy

  • Adequate organ and bone marrow function:

  • absolute neutrophil count greater than or equal to 1.5 times 10^9/L

  • platelet count greater than or equal to 100 times 10^9/L

  • hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment

  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)

  • calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)

  • international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

Exclusion Criteria:

  • Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)

  • Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway

  • Known human epidermal growth factor receptor 2 (HER2) positive

  • Untreated or symptomatic central nervous system (CNS) disease or brain metastases

  • Peripheral sensory neuropathy greater than or equal to Grade 2

  • Clinically significant cardiac disease

  • Other malignancy within the last 2 years (exceptions for definitively treated disease)

  • Chronic or systemic ophthalmological disorders

  • Major surgery or other investigational study within 28 days prior to first dose of study treatment

  • Palliative radiotherapy within 14 days prior to the first dose of study treatment

  • Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
2 Mayo Clinic Arizona Phoenix Arizona United States 85054
3 University of California Los Angeles Bowyer Hematology-Oncology Clinic Los Angeles California United States 90095
4 Innovative Clinical Research Institute Whittier California United States 90603
5 Mayo Clinic Florida Jacksonville Florida United States 32224
6 University of Michigan Ann Arbor Michigan United States 48109
7 Mayo Clinic Rochester Rochester Minnesota United States 55905
8 Healthier Hematology & Oncology Excelsior Integrated Medical Group Brooklyn New York United States 11220
9 White Plains Hospital Medical Center White Plains New York United States 10604
10 FirstHealth Outpatient Cancer Center Pinehurst North Carolina United States 28374
11 Avera Cancer Institute Sioux Falls South Dakota United States 57108
12 Sociedad de Beneficencia Hospital Italiano Cordoba Córdoba Argentina 5000
13 Exelsus Oncologia Clinica San Miguel de Tucuman Tucuman Argentina 4000
14 Instituto Argentino de Diagnostico y Tratamiento IADT Buenos Aires Argentina C1122AAL
15 Hospital Britanico de Buenos Aires Buenos Aires Argentina C1280AEB
16 Liverpool Hospital Liverpool New South Wales Australia 2170
17 St John of God Murdoch Hospital Murdoch Western Australia Australia 6150
18 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
19 Universitair Ziekenhuis Gent Gent Belgium 9000
20 Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven Belgium 3000
21 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 4000
22 Oncosite Centro de Pesquisa Clinica Em Oncologia LTDA Ijui Rio Grande Do Sul Brazil 98700-000
23 Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas Santo Andre São Paulo Brazil 09060-650
24 Multiprofile Hospital for Active Treatment Park Hospital EOOD Branipole Village Bulgaria 4109
25 Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD Haskovo Bulgaria 6300
26 University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Pleven Bulgaria 5800
27 University Multiprofile Hospital for Active Treatment Pulmed OOD Plovdiv Bulgaria 4002
28 Multiprofile Hospital for Active Treatment Serdika EOOD Sofia Bulgaria 1632
29 The Ottawa Hospital Cancer Centre Ottawa Ontario Canada K1H 8L6
30 Sunnybrook Research Institute Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
31 James Lind Centro de Investigacion del Cancer Temuco Cautín Chile 4800827
32 Clinica CIDO Temuco Cautín Chile 4810218
33 Centro de Estudios Clinicos SAGA Spa Santiago Chile 7500653
34 Biocinetic SpA Santiago Chile 8320000
35 Masarykuv onkologicky ustav Brno Czechia 656 53
36 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
37 Fakultni nemocnice Olomouc Olomouc Czechia 775 20
38 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
39 Fakultni Thomayerova nemocnice Praha 4 Czechia 140 59
40 Rigshospitalet Copenhagen Denmark 2100
41 North Estonia Medical Centre Foundation Tallinn Estonia 13419
42 Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord Saint Priest en Jarez France 42270
43 General Hospital of Athens Laiko Athens Greece 11527
44 Evgenidio Hospital I Agia Trias Athens Greece 11528
45 Metropolitan Hospital Athens Greece 18547
46 University Hospital of Heraklion Heraklion - Crete Greece 71110
47 University Hospital of Patras Patra Greece 26504
48 Anticancer Hospital of Thessaloniki Theageneio Thessaloniki Greece 54007
49 Bioclinic of Thessaloniki Thessaloniki Greece 54622
50 Petz Aladar Egyetemi Oktato Korhaz Gyor Hungary 9024
51 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Gyula Hungary 5700
52 Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz Miskolc Hungary 3526
53 Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz Nyiregyhaza Hungary 4400
54 Tolna Megyei Balassa Janos Korhaz Szekszard Hungary 7100
55 Istituto Ospedaliero Fondazione Poliambulanza Brescia Italy 25124
56 Presidio Ospedaliero Vito Fazzi Lecce Italy 73100
57 Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula Monserrato CA Italy 09042
58 Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemelli Roma Italy 00168
59 IRCCS Istituto Clinico Humanitas Rozzano MI Italy 20089
60 Azienda Ospedaliera Ordine Mauriziano di Torino Torino Italy 10128
61 Azienda Ospedaliera Cardinale Giovanni Panico Tricase Italy 73039
62 Azienda Ospedaliero Universitaria Integrata di Udine Udine Italy 33100
63 Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento Verona Italy 37126
64 Nagoya University Hospital Nagoya-shi Aichi Japan 466-8560
65 Chiba Cancer Center Chiba-shi Chiba Japan 260-8717
66 National Cancer Center Hospital East Kashiwa-shi Chiba Japan 277-8577
67 National Hospital Organization Shikoku Cancer Center Matsuyama-shi Ehime Japan 791-0280
68 National Hospital Organization Kyushu Cancer Center Fukuoka-shi Fukuoka Japan 811-1395
69 Gifu University Hospital Gifu-shi Gifu Japan 501-1194
70 Hokkaido University Hospital Sapporo Hokkaido Japan 060-8648
71 Hyogo Cancer Center Akashi-shi Hyogo Japan 673-8558
72 Kobe City Medical Center General Hospital Kobe-shi Hyogo Japan 650-0047
73 Yokohama City University Medical Center Yokohama-shi Kanagawa Japan 232-0024
74 Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Yokohama-shi Kanagawa Japan 241-8515
75 Niigata Cancer Center Hospital Niigata-shi Niigata Japan 951-8566
76 Kansai Medical University Hospital Hirakata-shi Osaka Japan 573-1191
77 Osaka International Cancer Institute Osaka-shi Osaka Japan 541-8567
78 Kindai University Hospital Osakasayama-shi Osaka Japan 589-8511
79 Osaka University Hospital Suita-shi Osaka Japan 565-0871
80 Shizuoka Cancer Center Sunto-gun Shizuoka Japan 411-8777
81 The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku Tokyo Japan 135-8550
82 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
83 Chungnam National University Hospital Daejeon Korea, Republic of 35015
84 Jeonbuk National University Hospital Jeonju-si, Jeollabuk-do Korea, Republic of 54907
85 Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do Korea, Republic of 13620
86 Korea University Anam Hospital Seoul Korea, Republic of 02841
87 Seoul National University Hospital Seoul Korea, Republic of 03080
88 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
89 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 03722
90 Asan Medical Center Seoul Korea, Republic of 05505
91 Samsung Medical Center Seoul Korea, Republic of 06351
92 The Catholic University of Korea Seoul St Marys Hospital Seoul Korea, Republic of 06591
93 Korea University Guro Hospital Seoul Korea, Republic of 08308
94 Pauls Stradins Clinical University Hospital Riga Latvia 1002
95 Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos Kaunas Lithuania 50161
96 Viesoji istaiga Klaipedos universitetine ligonine Klaipeda Lithuania 92288
97 Nacionalinis vezio institutas Vilnius Lithuania 08660
98 Vilnius University Hospital Santaros Clinic Public Institution Vilnius Lithuania 08661
99 Investigacion Biomedica para el Desarrollo de Farmacos SA de CV Zapopan Jalisco Mexico 45070
100 Christus Muguerza Clinica Vidriera Monterrey Nuevo León Mexico 64570
101 Investigación Biomédica para el Desarrollo de Fármacos SA de CV Aguascalientes Mexico 20010
102 Trials In Medicine SC Ciudad de Mexico Mexico 06700
103 Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy Bydgoszcz Poland 85-796
104 Szpitale Pomorskie Spzoo Gdynia Poland 81-519
105 SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu Opole Poland 45-060
106 Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie Poznan Poland 61-866
107 Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Przemysl Poland 37-700
108 Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal Radom Poland 26-600
109 Hospital da Senhora da Oliveira, Guimaraes, EPE Guimaraes Portugal 4835-044
110 Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia Mare Baia Mare Romania 430031
111 Institutul Clinic Fundeni Bucharest Romania 022328
112 Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti Bucuresti Romania 022338
113 SC Medisprof SRL Cluj-Napoca Romania 400058
114 Institutul Regional de Oncologie Iasi Iasi Romania 700483
115 Ovidius Clinical Hospital Ovidiu Romania 905900
116 National Cancer Centre Singapore Singapore Singapore 169610
117 Hospital Universitario Reina Sofia Cordoba Andalucía Spain 14004
118 Hospital Regional Universitario de Malaga Malaga Andalucía Spain 29010
119 Hospital Universitario Miguel Servet Zaragoza Aragón Spain 50009
120 Hospital Universitario de Burgos Burgos Castilla León Spain 09006
121 Hospital Clinic i Provincial de Barcelona Barcelona Cataluña Spain 08036
122 Corporacio Sanitaria Parc Tauli Sabadell Cataluña Spain 08208
123 Hospital Universitari i Politecnic La Fe Valencia Comunidad Valenciana Spain 46026
124 Complexo Hospitalario Universitario de Ourense Ourense Galicia Spain 32005
125 Hospital Donostia San Sebastian País Vasco Spain 20014
126 Hospital General Universitario Gregorio Marañon Madrid Spain 28009
127 Hospital General Universitario Jose Maria Morales Meseguer Murcia Spain 30008
128 Sahlgrenska Universitetssjukhuset Göteborg Sweden 413 45
129 Karolinska Universitetssjukhuset Huddinge Stockholm Sweden 141 86
130 Norrlands Universitetssjukhus Umea Sweden 901 85
131 National Cheng Kung University Hospital Tainan Taiwan 70403
132 Tri-Service General Hospital Taipei Taiwan 11490
133 Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi Adana Turkey 01250
134 Hacettepe Universitesi Tip Fakultesi Ankara Turkey 06230
135 Ankara Sehir Hastanesi Ankara Turkey 06800
136 Dicle Universitesi Tip Fakultesi Diyarbakir Turkey 21080
137 Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Istanbul Turkey 34093
138 Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul Turkey 34722
139 Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi Izmir Turkey 35150
140 Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi Samsun Turkey 55200
141 Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi Van Turkey 65000

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05052801
Other Study ID Numbers:
  • 20210096
First Posted:
Sep 22, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Bemarituzumab
FGFR2b Overexpression
Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Bemarituzumab

Study Results

No Results Posted as of Aug 12, 2022