Clinical trial • Phase III • Oncology
SELPERCATINIB for Medullary thyroid cancer (RET‑mutant)
Phase III trial of SELPERCATINIB for Medullary thyroid cancer (RET‑mutant).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Medullary thyroid cancer (RET‑mutant)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 28-03-2024
- First CTIS Authorization Date
- 16-05-2024
Trial design
Randomised, open-label, physician's choice of cabozantinib or vandetanib (oral capsules); specific doses and schedules are not specified in the provided record.-controlled, crossover Phase III trial across 38 sites in Belgium, Czechia, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Physician's choice of Cabozantinib or Vandetanib (oral capsules); specific doses and schedules are not specified in the provided record.
- Crossover
- Yes
- Target Sample Size
- 159
Eligibility
Recruits 159 paediatric patients.
- Vulnerable Population
- Vulnerable populations include minors: study documents include parent/guardian informed consent forms and assent forms. Materials and addenda are provided for children aged 12-14 and 15-17 (assent forms), parent/legal representative consent forms, and parent addenda for prescreening and switch/crossover. Country-specific informed consent/assent documents and addenda are provided (multiple language versions indicated in document listings).
Inclusion criteria
- {"criterion_text":"- Participants must have medullary thyroid cancer that is not able to be removed by surgery or has spread to other places in the body, has not been treated with certain medications previously, and has evidence on imaging studies that the cancer has gotten bigger in the previous 14 months"}
- {"criterion_text":"- Participants must have evidence that their cancer is caused by a mutation in the RET gene"}
- {"criterion_text":"- Participants must be in fair to good general health and not have another serious medical condition"}
- {"criterion_text":"- Participants must be willing to use highly effective contraception during the study"}
Exclusion criteria
- {"criterion_text":"- Participants must not have cancer that has spread to the brain or spinal cord that is causing symptoms"}
- {"criterion_text":"- Participants must not have a heart condition that puts you at risk for abnormal heart rhythms"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS by BICR","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 159
- Recruitment Window Months
- 97
- Consent Approach
- Informed consent obtained from adult participants; for minors parental/legal representative consent is required and child assent is obtained. Age-specific documents exist for assent and consent (assent forms and addenda for ages 12-14 and 15-17, parent addenda, legal representative forms, prescreening addenda, crossover and switch addenda). Multiple language and country-specific versions of ICF/SIS and assent forms are provided (documents listed for EN, FR, NL, CZ, PL, IT, GR and country-specific sets).
Methods
- Recruitment arrangements and materials including Dear Doctor letters, Investigator letters, flyers and patient brochures (documents titled K2_Recruitment Material_Flyer, K2_Recruitment Material_Investigator Letter, K2_Recruitment Material_Dear Doctor letter, L6_Other subject information Patient Brochure). Target audiences: physicians/investigators and patients.
- Site listings and planned site lists (document: K3_List of planned sites_Belgium_Redacted) used to engage sites for recruitment.
- Patient referral and recruitment vendors engaged (third parties listed with duties for Patient Referral, Recruitment, Screening, and/or Retention).
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 114
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 698
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Contact Person Name
- Laurence Lousberg
- Contact Person Email
- Laurence.Lousberg@chuliege.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 698
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Univerzita Karlova 2 Lekarska Fakulta
- Department Name
- Onkologicka klinika 2. LF UK a FN Motol
- Contact Person Name
- Kateřina Kopečková
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
France
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 700
- Number Of Sites
- 12
- Number Of Participants
- 36
Sites
- Site Name
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
- Department Name
- Oncologie
- Contact Person Name
- Marie-Eve Garcia
- Contact Person Email
- marie-eve.garcia@ap-hm.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Oncologie
- Contact Person Name
- Hakim Mahammedi
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie
- Contact Person Name
- Sylvie Zanetta
- Contact Person Email
- szanetta@cgfl.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie
- Contact Person Name
- Julien Hadoux
- Contact Person Email
- julien.hadoux@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie
- Contact Person Name
- Thibault Gauduchon
- Contact Person Email
- thibault.gauduchon@lyon.unicancer.fr
- Site Name
- University Hospitals Pitie Salpetriere Charles Foix
- Department Name
- Oncologie
- Contact Person Name
- Camille Buffet
- Contact Person Email
- camille.buffet@aphp.fr
- Site Name
- Centre Paul Strauss
- Department Name
- Oncologie
- Contact Person Name
- Mickael Burgy
- Contact Person Email
- m.burgy@icans.eu
- Site Name
- Institut Bergonie
- Department Name
- Oncologie
- Contact Person Name
- Yann Godbert
- Contact Person Email
- y.godbert@bordeaux.unicancer.fr
- Site Name
- Hôpital Claude Huriez - CHU de Lille
- Department Name
- Oncologie
- Contact Person Name
- Christine Do Cao
- Contact Person Email
- christine.docao@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Oncologie
- Contact Person Name
- Patrice Rodien
- Contact Person Email
- parodien@chu-angers.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Oncologie
- Contact Person Name
- Camila NASCIMENTO
- Contact Person Email
- nascimento.camila@iuct-oncopole.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncologie
- Contact Person Name
- Stephane Bardet
- Contact Person Email
- sbardet@baclesse.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-05-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 675
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Endokrinologie und Stoffwechselerkrankungen
- Contact Person Name
- Matthias M. Weber
- Contact Person Email
- mmweber@uni-mainz.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Contact Person Name
- Michael Kreissl
- Contact Person Email
- michael.kreissl@med.ovgu.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation
- Contact Person Name
- Christoph Reuter
- Contact Person Email
- reuter.christoph@mh-hannover.de
- Site Name
- Universitaetsklinikum Essen
- Department Name
- Klinik für Endokrinologie, Diabetologie und Stoffwechsel
- Contact Person Name
- Dagmar Fuehrer-Sakel
- Contact Person Email
- dagmar.fuehrer-sakel@uk-essen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Endocrinology and Metabolism
- Contact Person Name
- Knut Mai
- Contact Person Email
- knut.mai@charite.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik Und Poliklinik 1
- Contact Person Name
- Matthias Kroiss
- Contact Person Email
- matthias.kroiss@med.uni-muenchen.de
- Site Name
- München Campus Großhadern - Medizinische Klinik und Poliklinik IV
- Department Name
- Medizinische Klinik und Poliklinik IV
- Contact Person Name
- Christine Spitzweg
- Contact Person Email
- med4.studien-endokrinologie@med.uni-muenchen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 697
- Number Of Sites
- 6
- Number Of Participants
- 19
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SC Oncologia Medica 3 - Tumori Testa-collo
- Contact Person Name
- Lisa Licitra
- Contact Person Email
- lisa.licitra@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Dipartimento di Medicina Traslazionale e di Precisione
- Contact Person Name
- Cosimo Durante
- Contact Person Email
- cosimo.durante@uniroma1.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Department of Clinical and Experimental Medicine - Endocrine Unit
- Contact Person Name
- Rossella Elisei
- Contact Person Email
- rossella.elisei@med.unipi.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Endocrinologia Oncologica
- Contact Person Name
- Marialuisa Appetecchia
- Contact Person Email
- marialuisa.appetecchia@ifo.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Public Health
- Contact Person Name
- Domenico Salvatore
- Contact Person Email
- domsalva@unina.it
- Site Name
- Istituto Auxologico Italiano
- Department Name
- Division of Endocrine and Metabolic Diseases
- Contact Person Name
- Carla Colombo
- Contact Person Email
- c.colombo@auxologico.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 701
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Oncology
- Contact Person Name
- Esther Broekman
- Contact Person Email
- k.e.broekman@umcg.nl
- Site Name
- University Hospital Maastricht
- Department Name
- Oncology
- Contact Person Name
- Johanna Nin
- Contact Person Email
- johanna.nin@mumc.nl
- Site Name
- Netherlands Cancer Institute
- Department Name
- Oncology
- Contact Person Name
- Jan de Boer
- Contact Person Email
- j.d.boer@nki.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Oncology
- Contact Person Name
- Hans Kapiteijn
- Contact Person Email
- h.w.kapiteijn@lumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 701
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact Person Name
- Barbara Jarząb
- Contact Person Email
- barbara.jarzab@io.gliwice.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Contact Person Name
- Aldona Kowalska
- Contact Person Email
- Aldona.Kowalska@onkol.kielce.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 704
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Oncology
- Contact Person Name
- Beatriz Castelo Fernandez
- Contact Person Email
- castelobeatriz@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Hospital General Universitario Gregorio Marañón
- Department Name
- Oncology
- Contact Person Name
- Marta Arregui Valles
- Contact Person Email
- martitaav2@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- Jaume Capdevila Castillon
- Contact Person Email
- jcapdevila@vhio.net
Greece
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 620
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Alexandra Hospital
- Department Name
- University Clinic of Therapeutics
- Contact Person Name
- Flora Zagouri
- Contact Person Email
- florazagouri@yahoo.co.uk
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Sponsor duties code 6 (clinical trial support)
- Name
- Iqvia Rds Inc.
- Responsibilities
- Clinical operations and data responsibilities (sponsor duties codes 1 and 5)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Sponsor duties code 10
Third parties
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Sponsor duties code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Clinical Trial Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Rebar Interactive LLC","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Sponsor duties code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Modus Outcomes","duties_or_roles":"Patient Report Outcomes (PRO) Development","organisation_type":"Health care"}
- {"country":"United Kingdom","full_name":"Colpitts Clinical","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Health care"}
- {"country":"United States","full_name":"Life Technologies","duties_or_roles":"Laboratory/testing support (sponsor duties code 4)","organisation_type":"Industry"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Adjudication; sponsor duties code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Data management/clinical operations (sponsor duties codes 1 and 5)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Sponsor duties code 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Brightech International, LLC","duties_or_roles":"Sponsor duties code 10","organisation_type":"Health care"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Sponsor duties code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SELPERCATINIB
- Active Substance
- SELPERCATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Not authorised
- Investigational Product Name
- Cabozantinib
- Active Substance
- CABOZANTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Investigational Product Name
- VANDETANIB
- Active Substance
- VANDETANIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Not authorised
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