A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-301)

A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Bemarituzumab

• Study Type: Interventional
• Enrollment (Estimated): 303
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Recruiting
    • Centro Oncológico Korben
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, C1426ANZ
      • Recruiting
      • Instituto Alexander Fleming
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
      • Recruiting
      • Hospital Alemán
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
      • Recruiting
      • Fundacion Cenit Para La Investigacion
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Hospital Italiano de La Plata
  • Córdoba
    • Cordoba, Córdoba, Argentina, 5000
      • Recruiting
      • Sociedad de Beneficencia Hospital Italiano
  • Río Negro
    • Cipolletti, Río Negro, Argentina, 8324
      • Recruiting
      • Fundacion Medica de Rio Negro y Neuquen
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Prince of Wales Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Wollongong Hospital
  • Queensland
    • Toowoomba, Queensland, Australia, 4350
      • Recruiting
      • Toowoomba Hospital
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Recruiting
      • St John of God Murdoch Hospital
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universitaet Graz
  • Salzburg, Austria, 5020
    • Recruiting
    • Landeskrankenhaus Salzburg
• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 5530
    • Recruiting
    • Grand Hôpital de Charleroi
  • Edegem, Belgium, 2650
    • Recruiting
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
• Brazil
  • Rio de Janeiro, Brazil, 22250-905
    • Recruiting
    • Oncoclinicas Rio de Janeiro S A
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Recruiting
      • Hospital Das Clinicas Da Ufmg
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-220
      • Recruiting
      • Centro de Oncologia Mackenzie
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Recruiting
      • Associacao Hospitalar Moinhos de Vento
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 01221-020
      • Recruiting
      • Instituto do Cancer Arnaldo Vieira de Carvalho
    • Sao Paulo, São Paulo, Brazil, 01323-900
      • Recruiting
      • Beneficencia Portuguesa de Sao Paulo
    • Sao Paulo, São Paulo, Brazil, 04501-000
      • Recruiting
      • Oncologia Rede D Or
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  • Plovdiv, Bulgaria, 4004
    • Recruiting
    • Complex Oncology Center Plovdiv EOOD
  • Sofia, Bulgaria, 1606
    • Recruiting
    • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
• Canada
  • Toronto, Canada, M5G 1Z5
    • Recruiting
    • Princess Margaret Cancer Centre
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital Cancer Centre
• Czechia
  • Brno, Czechia, 656 53
    • Recruiting
    • Masarykuv onkologicky ustav
  • Hradec Kralove, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc
  • Praha 10, Czechia, 100 34
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady
• Denmark
  • Kobenhavn O, Denmark, 2100
    • Recruiting
    • Rigshospitalet
• Finland
  • Helsinki, Finland, 00180
    • Recruiting
    • Docrates Syopasairaala
  • Tampere, Finland, 33521
    • Recruiting
    • Tampere University Hospital
• France
  • Angers Cedex 02, France, 49055
    • Recruiting
    • Institut de Cancerologie de l Ouest Rene Gauducheau
  • Besancon cedex, France, 25030
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
  • Lille Cedex, France, 59020
    • Recruiting
    • Centre Oscar Lambret
  • Marseille Cedex 09, France, 13272
    • Recruiting
    • Institut Paoli Calmettes
  • Montpellier Cedex 5, France, 34298
    • Recruiting
    • Institut régional du cancer Montpellier
  • Pierre-Benite, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud
  • Toulouse cedex 9, France, 31059
    • Recruiting
    • Institut Claudius Regaud
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Sotiria General Hospital
  • Athens, Greece, 11528
    • Recruiting
    • Alexandra Hospital
  • Athens, Greece, 15562
    • Recruiting
    • Metropolitan General
  • Heraklion - Crete, Greece, 71500
    • Recruiting
    • University Hospital of Heraklion
  • Thessaloniki, Greece, 57001
    • Recruiting
    • European Interbalkan Medical Center
• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1082
    • Recruiting
    • Semmelweis Egyetem
  • Nyiregyhaza, Hungary, 4400
    • Recruiting
    • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
  • Szolnok, Hungary, 5000
    • Recruiting
    • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Ein-Kerem Medical Center
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Foggia, Italy, 71100
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  • Mirano, Italy, 30035
    • Recruiting
    • Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
  • Napoli, Italy, 80147
    • Recruiting
    • Ospedale del Mare
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Recruiting
      • Kindai University Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Mexico
  • Baja California Sur
    • La Paz, Baja California Sur, Mexico, 23040
      • Terminated
      • Investigación Onco Farmacéutica S de RL de CV
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25279
      • Recruiting
      • Centro de Infusion e Investigacion Oncologia de Saltillo
  • Distrito Federal
    • Ciudad de Mexico, Distrito Federal, Mexico, 03103
      • Recruiting
      • Investigación Biomédica para el Desarrollo de Fármacos
    • Mexico City, Distrito Federal, Mexico, 03100
      • Recruiting
      • Health Pharma Professional Research SA de CV
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64570
      • Terminated
      • Christus Muguerza Clinica Vidriera
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • Universitair Medisch Centrum Groningen
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Radboud Universitair Medisch Centrum
• Poland
  • Krakow, Poland, 30-727
    • Recruiting
    • Pratia MCM Krakow
  • Lodz, Poland, 93-338
    • Recruiting
    • Instytut Centrum Zdrowia Matki Polki
  • Pila, Poland, 64-920
    • Recruiting
    • Ars Medical Spzoo
  • Siedlce, Poland, 08-110
    • Recruiting
    • Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
  • Skorzewo, Poland, 60-185
    • Recruiting
    • Centrum Medyczne Pratia Poznan
• Portugal
  • Lisboa, Portugal, 1649-035
    • Recruiting
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz, SA
  • Lisboa, Portugal, 1440-005
    • Recruiting
    • Centro Hospitalar de Lisboa Ocidental, EPE, Hospital Sao Francisco Xavier
• Romania
  • Cluj Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
  • Craiova, Romania, 200347
    • Recruiting
    • Centrul de Oncologie Sf Nectarie SRL
  • Iasi, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie Iasi
  • Timisoara, Romania, 300239
    • Recruiting
    • SC Oncomed SRL
• Spain
  • Andalucía
    • Malaga, Andalucía, Spain, 29010
      • Recruiting
      • Hospital Clinico Universitario Virgen de la Victoria
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Recruiting
      • Hospital Clinico Universitario de Santiago
• Switzerland
  • Chur, Switzerland, 7000
    • Recruiting
    • Kantonsspital Graubuenden
  • Geneve, Switzerland, 1205
    • Recruiting
    • Hôpitaux universitaires de Genève
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Christie Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Recruiting
    • Weston Park Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope National Medical Center
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80218
      • Recruiting
      • US Oncology Regulatory Affairs Corporate Office
    • Denver, Colorado, United States, 80218
      • Recruiting
      • US Oncology Research Investigational Products Center
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Completed
      • Community Health Network MD Anderson Cancer Center - North
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Completed
      • Henry Ford Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology - Dallas Fort Worth
    • Houston, Texas, United States, 77030
      • Completed
      • University of Texas MD Anderson Cancer Center
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology Northeast Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed

2. Histologically or cytologically confirmed cancer of one of the following types, refractory to or relapsed after at least 1 prior standard therapeutic regimen in the advanced/metastatic setting, as specified below. If no standard of care therapies exist for the participant, or the participant cannot tolerate or refuses standard of care anticancer therapy, the participant may be allowed to participate on the study after discussion between the investigator and Amgen medical monitor. Participants who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving bemarituzumab are available prior to consenting to participate in the trial.

   • head and neck squamous cell carcinoma: ≥ 1 line of therapy
   • triple-negative breast cancer: ≥ 2 lines of therapy
   • Intrahepatic cholangiocarcinoma ≥ 1 line of therapy
   • lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapy
   • platinum resistant ovarian epithelial cell carcinoma, including fallopian tube cancers and primary peritoneal cancers, defined as progression during or within 6 months of a platinum containing regimen: ≥ 1 line of therapy
   • endometrial adenocarcinoma: ≥ 1 line of therapy
   • cervical carcinoma: ≥ 1 line of therapy
   • other solid tumors: ≥ 1 line of therapy
3. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
4. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
5. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function as determined per protocol.

Exclusion Criteria:

1. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
2. Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma
3. Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction ≥ 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval QTc ≥ 470
4. History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
5. Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
6. Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment
7. Recent (within 6 months) corneal surgery or ophthalmic laser treatment or recent (within 6 months) history of, or evidence of, corneal defects, corneal ulcerations, keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer prior/concomitant therapy
8. Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Monotherapy Dose Exploration; Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive 1 of 2 dose regimens of bemarituzumab to determine recommended Phase 2 dose.	Drug: Bemarituzumab; Intravenous (IV) infusion.; Other Names: AMG 552
Experimental: Part 2: Monotherapy Dose Expansion; Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive the dose of bemarituzumab identified as the recommended Phase 2 dose during Part 1.	Drug: Bemarituzumab; Intravenous (IV) infusion.; Other Names: AMG 552

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)		Day 1 to Day 28
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)	Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.	Day 1 to 28 days after last dose (a maximum of 2 years)
Part 1: Number of Participants Who Experience a Treatment-related Adverse Event		Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Objective Response (OR) Rate	OR = complete response (CR) + partial response (PR), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: OR Rate	OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.	Up to approximately 2 years
Parts 1 and 2: Disease Control (DC) Rate	DC = CR, PR, or stable disease (SD).	Up to approximately 2 years
Parts 1 and 2: Duration of Response (DOR)	DOR, defined as the time from first documentation of OR (as determined by investigator per RECIST v1.1) until the first documentation of disease progression or death due to any cause, whichever occurs first. Only participants who have achieved OR will be evaluated for DOR. DOR will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy.	Up to approximately 2 years
Parts 1 and 2: Time to Response		Up to approximately 2 years
Parts 1 and 2: Progression-free Survival (PFS)	PFS, defined as time from first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause. PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent therapy. Progression will be based on RECIST v1.1 (derived utilizing investigator tumor assessments).	Up to approximately 2 years
Parts 1 and 2: Overall Survival (OS)	OS, defined as time from first dose of investigational product until death from any cause. Participants still alive will be censored at the date last known to be alive.	Up to approximately 2 years
Part 2: Number of Participants Who Experience a TEAE	AEs are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.	Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Number of Participants Who Experience a Treatment-related AE		Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab		Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab		Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab		Day 1 to 28 days after last dose (a maximum of 2 years)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): September 8, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Head and neck squamous cell carcinoma; Triple-negative breast cancer; Bemarituzumab; AMG 552; Cervical carcinoma; Epithelial solid tumors with fibroblast growth factor receptor 2b overexpression; FGFR2b; Intrahepatic cholangiocarcinoma; Lung adenocarcinoma; Ovarian epithelial carcinoma; Endometrial adenocarcinoma; Other solid tumors
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Bemarituzumab
• Other Study ID Numbers: 20210104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No