Clinical trial • Phase III • Oncology|Rare Disease

TOVORAFENIB for Pediatric low-grade glioma (RAF-altered)

Phase III trial of TOVORAFENIB for Pediatric low-grade glioma (RAF-altered).

Overview

Trial Therapeutic Area
Oncology|Rare Disease
Trial Disease
Pediatric low-grade glioma (RAF-altered)
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
25-09-2024
First CTIS Authorization Date
29-10-2024

Trial design

Randomised, open-label, standard of care (soc) chemotherapy comparator arms including vincristine-based regimens and vinblastine or carboplatin regimens. comparator products listed: vincrisin 1 mg/ml solution injectable (vincristine sulfate) iv; cellcristin® 1 mg/ml (vincristine sulfate) iv; vincristinesulfaat teva 1 mg/ml iv; velbe 10 mg (vinblastine sulfate) iv; vinblastin stada 10 mg powder for injection (vinblastine sulfate) iv; carboplatin hikma 10 mg/ml concentrate for infusion (carboplatin) iv. regimen durations described in protocol: 60 weeks for cog-vc, 81 weeks for siope-lgg-v/c, 70 weeks for vbl, or 72 weeks for monthly carboplatin. test arm: day101 (tovorafenib) monotherapy (oral tablet or powder for oral suspension) until progression/unacceptable toxicity/withdrawal/end of study.-controlled Phase III trial in Denmark, Spain, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of Care (SoC) chemotherapy comparator arms including vincristine-based regimens and vinblastine or carboplatin regimens. Comparator products listed: VINCRISIN 1 mg/ml solution injectable (vincristine sulfate) IV; cellcristin® 1 mg/ml (vincristine sulfate) IV; Vincristinesulfaat Teva 1 mg/ml IV; VELBE 10 mg (vinblastine sulfate) IV; Vinblastin STADA 10 mg powder for injection (vinblastine sulfate) IV; Carboplatin Hikma 10 mg/ml concentrate for infusion (carboplatin) IV. Regimen durations described in protocol: 60 weeks for COG-VC, 81 weeks for SIOPe-LGG-V/C, 70 weeks for VBL, or 72 weeks for monthly carboplatin. Test arm: DAY101 (tovorafenib) monotherapy (oral tablet or powder for oral suspension) until progression/unacceptable toxicity/withdrawal/end of study.
Target Sample Size
155
Trial Duration For Participant
567

Eligibility

Recruits 155 paediatric patients.

Vulnerable Population
The study enrols children and adolescents (patients <25 years) and explicitly includes minors. The documentation package contains age‑appropriate assent forms (examples in documents: Assent 11 years and younger; Assent 12-14 years; Assent 15-17 years; Assent 7-12 years; Assent 13 years and older, etc.) and parental/guardian main consent forms (Parental Main, Parental Optional Tumor, Parental Optional Biobank, Power of Attorney Between Parents). Site-specific 'Scout' procedures and site information are provided to support identification and approach of potential pediatric participants. Consent/assent materials are translated/localised for participating countries (multiple language versions available: Danish, Spanish, Dutch, Hungarian, Greek, Italian, French, German, Czech, Swedish, Finnish, Slovenian, etc.).

Inclusion criteria

  • {"criterion_text":"- Less than 25 years of age with LGG with known activating RAF alteration\n- Histopathologic diagnosis of glioma or glioneuronal tumor\n- At least one measurable lesion\n- Meet indication for first-line systemic therapy"}

Exclusion criteria

  • {"criterion_text":"- Patient has any of the following tumor-histological findings: a. \tSchwannoma b. \tSubependymal giant cell astrocytoma (Tuberous Sclerosis) c. \tDiffuse intrinsic pontine glioma, even if histologically diagnosed as WHO Grade I-II\n- Patient's tumor has additional pathogenic molecular alterations\n- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF1/NF-2)\n- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ORR, per RAPNO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).","definition_or_measurement_approach":"ORR assessed per RAPNO criteria by Independent Review Committee (IRC); defined as proportion of patients with confirmed overall response of CR, PR, or MR."}

Secondary endpoints

  • {"endpoint_text":"- PFS per RAPNO criteria, defined as time from randomization to progressive disease (PD) or death from any cause, whichever comes first.","definition_or_measurement_approach":"PFS assessed per RAPNO criteria by IRC; time from randomization to PD or death (any cause)."}
  • {"endpoint_text":"- EFS per RAPNO criteria, defined as time from randomization to PD, death from any cause, or initiation of any new anticancer therapy, whichever comes first.","definition_or_measurement_approach":"EFS assessed per RAPNO criteria by IRC; time from randomization to PD, death, or start of new anticancer therapy, whichever occurs first."}
  • {"endpoint_text":"- OS, defined as time from randomization up to death from any cause.","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}

Recruitment

Planned Sample Size
155
Recruitment Window Months
89
Consent Approach
Informed consent is obtained from parents/legal guardians for minors; age‑appropriate assent is obtained from children/adolescents with dedicated assent documents (multiple age bands: e.g., assent for 11 years and younger, 12-14 years, 15-17 years, 7-12 years, 13 years and older, etc.). There are parental main consent forms and participant main consent forms, plus addenda for optional tumor specimen collection, optional biobank, pregnant partner data collection, continuation, and treatment‑beyond‑progression. A Power of Attorney Between Parents document is available where relevant. Consent/assent materials and supporting documents are provided in local languages for participating countries; site-specific procedures (K1 recruitment procedure documents) and Scout agreements describe how potential participants are approached. Participant safety follow-up (30-day safety follow-up) and long-term follow-up procedures are included in the protocol and consent materials.

Methods

  • Physician referral letters and HCP outreach (documents: Physician Referral Letter; country-specific K1/K2 recruitment procedures) — channel: hospital clinicians and pediatric oncology departments; target audience: treating pediatric oncologists; country-specific procedures present (examples: K1/K2 documents for NL, ES, IT, DE, DK, HU, NO, IE, EL, BE, FR, FI, SE, CZ, SI).
  • Patient-facing trial cards and informational materials (Trial Card / Patient Facing Trial Card) in local languages for direct patient/parent information — channel: printed materials given in clinic; target audience: patients/parents (pediatric patients) and guardians; country-specific translations present.
  • Healthcare professional trial cards (HCP Trial Card) to inform clinicians about trial eligibility and contact information — channel: HCP-targeted materials; target audience: referring physicians and hospital staff.
  • Scout program / scout agreements (Scout Clinical; Scout Agreement documents) to support identification of potential participants in the community and by site-designated scouts.
  • Site-based recruitment via pediatric oncology clinics and tumor boards (sites listed per country with pediatric oncology departments).
  • Use of standard site communications / translations support (Transperfect Translations) and EDC contact (Medidata Rave) to manage and support trial communications and enrollment logistics.

Geography

Total Number Of Sites
57
Total Number Of Participants
245

Denmark

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
04-11-2024
Processing Time Days
24
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Rigshospitalet
Department Name
Department of Pediatric Hematology and Oncology Department of Pediatric and Adolescence Medicine
Contact Person Name
Astrid Sehested
Site Name
Aarhus Universitetshospital
Department Name
Department of Pediatrics and Adolescent Medicine
Contact Person Name
Louise Henriksen
Contact Person Email
louhen@rm.dk

Spain

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
31-10-2024
Processing Time Days
20
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Pediatric Oncology Department
Contact Person Name
Anna Llort
Contact Person Email
anna.llort@vallhebron.cat
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Pediatric Oncology Department
Contact Person Name
Miriam Pavón Mengual
Contact Person Email
miriam.pavon@sjd.es
Site Name
Hospital Universitario De Cruces
Department Name
Pediatric Hemato-Oncology Department
Contact Person Name
Miguel Alejandro Garcia-Ariza
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Hemato-Oncology Department
Contact Person Name
Adela Cañete
Contact Person Email
canyete_ade@gva.es
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Hemato-Oncology Department
Contact Person Name
Diego Plaza López de Sabando
Contact Person Email
diego.plaza@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric Oncology Department
Contact Person Name
Palma Solano Paez
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric Hemato-Oncology Department
Contact Person Name
Alvaro Lassaletta Atienza

Netherlands

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
29-10-2024
Processing Time Days
18
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Pediatric hemato-Oncology
Contact Person Name
Jasper van der Lugt

Slovenia

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
08-11-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
University Medical Center Ljubljana
Department Name
Department of Hematology and Oncology
Contact Person Name
Barbara Faganel Kotnik
Contact Person Email
barbara.faganel@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
25
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Department für Kinder- und Jugendheilkunde
Contact Person Name
Roman Crazzolara
Contact Person Email
roman.crazzolara@i-med.ac.at
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Neurologie
Contact Person Name
Amedeo Azizi
Contact Person Email
amedeo.azizi@meduniwien.ac.at

Hungary

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Semmelweis University
Department Name
Oncology
Contact Person Name
Miklós Garami
Contact Person Email
miklos.garami@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Oslo University Hospital HF
Department Name
Oncology and Hematology
Contact Person Name
Aina Ulvmoen
Contact Person Email
ainulv@ous-hf.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Oncology and Hematology
Contact Person Name
Ole Mikal Wormdal
Contact Person Email
ole.mikal.wormdal@unn.no

Ireland

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Children's Health Ireland
Department Name
Division of Haematology/Oncology
Contact Person Name
Sarah Curry
Contact Person Email
sarah.curry@olchc.ie

Greece

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
09-12-2024
Processing Time Days
59
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
Unit of Pediatric Hematology and Oncology, First Department of Pediatrics.
Contact Person Name
Antonis Kattamis
Contact Person Email
ankatt@med.uoa.gr
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Oncology Department
Contact Person Name
Dimitrios Doganis
Contact Person Email
doganisd@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
UZ Leuven
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Sandra Jacobs
Contact Person Email
tessa.deroo@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric Hemato-Oncology
Contact Person Name
Leen Willems
Contact Person Email
gudrun.lerno@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric hemato-oncology
Contact Person Name
An van Damme

France

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
33
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
La Timone Children Hospital, Department of Pediatric Hematology Oncology
Contact Person Name
Nicolas Andre
Contact Person Email
Nicolas.andre@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Institute of Pediatric Hematology and Oncology (iHOPe) GCS Lyon University Oncology
Contact Person Name
Pierre Leblond
Contact Person Email
pierre.leblond@ihope.fr
Site Name
Institut Gustave Roussy
Department Name
Pediatric Unit
Contact Person Name
Samuel Abbou
Contact Person Email
Samuel.abbou@gustaveroussy.fr
Site Name
Centre Oscar Lambret
Department Name
Pediatric Unit. Oncology department
Contact Person Name
Sandra Raimbault
Contact Person Email
s-raimbault@o-lambret.fr
Site Name
Institut Curie
Department Name
Pediatric department
Contact Person Name
François Doz
Contact Person Email
Francois.doz@curie.fr

Italy

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
04-11-2024
Processing Time Days
24
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
P.O. Santa Maria della Misericordia SOC Clinica Pediatrica
Contact Person Name
Chiara Pilotto
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOSD NeuroOncology
Contact Person Name
Carla Fonte
Contact Person Email
carla.fonte@meyer.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Dipartimento di Oncoematologia, Terapia Cellulare, Terapie Geniche e trapianto Emopoietico
Contact Person Name
Angela Mastronuzzi
Contact Person Email
angela.mastronuzzi@opbg.net
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia ed Ematologia
Contact Person Name
Elisabetta Schiavello
Site Name
University Hospital Consorziale Policlinico
Department Name
Unità Operativa Complessa di Pediatria ad Indirizzo Oncoematologico
Contact Person Name
Teresa Perillo
Contact Person Email
terryperillo@hotmail.com
Site Name
Azienda Ospedaliera di Padova
Department Name
Oncoematologia Pediatrica
Contact Person Name
Elisabetta Viscardi
Contact Person Email
elisabetta.viscardi@unipd.it
Site Name
Azienda Ospedaliera Santobono Pausilipon
Department Name
Dipartimento di Oncologia Pediatrica
Contact Person Name
Lucia Quaglietta
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Emato-Oncologia Pediatrica
Contact Person Name
Claudia Milanaccio
Contact Person Email
claudiamilanaccio@gaslini.org
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Oncoematologia Pediatrica
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it

Finland

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
HUS-Yhtymae
Department Name
Hematology and oncology
Contact Person Name
Satu Langström
Contact Person Email
satu.langstrom@hus.fi
Site Name
Tampere University Hospital
Department Name
Hematology and oncology
Contact Person Name
Kristiina Nordfors
Contact Person Email
kristiina.nordfors@pirha.fi

Sweden

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-10-2024
Processing Time Days
19
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Pediatric Cancer center, Skånes Universitetssjukhus Lund
Contact Person Name
Helena Morse
Contact Person Email
helena.morse@skane.se
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital
Department Name
Pediatric Clinical Research Center, Drottning Silivias barnsjukhus
Contact Person Name
Aron Onerup
Contact Person Email
aron.onerup@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Childhood cancer center, Astrid Lindgrens Barnsjukhus
Contact Person Name
Tomas Sjöberg Bexelius

Germany

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
25
Number Of Sites
14
Number Of Participants
35

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Pediatrics III
Contact Person Name
Stephan Tippelt
Contact Person Email
Stephan.tippelt@uk-essen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinische Kooperationseinheit Pädiatrische Onkologie
Contact Person Name
Olaf Witt
Contact Person Email
o.witt@kitz-heidelberg.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Kinder und Jugendklinik
Contact Person Name
Markus Metzler
Contact Person Email
markus.metzler@uk-erlangen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Pädiatrische Klinik mit Schwerpunkt Onkologie und Hämatologie
Contact Person Name
Pablo Hernáiz Driever
Contact Person Email
pablo.hernaiz@charite.de
Site Name
Universitaet Leipzig
Department Name
Kinderklinik, selbst. Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
Contact Person Name
Susanne Wendt
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Clinic for Pediatrics and Adolescent Medicine
Contact Person Name
Jan-Henning Klusmann
Contact Person Email
kkjm-direktor@ukffm.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Campus Bielefeld-Bethel, Universitätsklinik für Kinder- und Jugendmedizin
Contact Person Name
Norbert Jorch
Contact Person Email
norbert.jorch@evkb.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Paediatric Haematology and Oncology
Contact Person Name
Uwe Kordes
Contact Person Email
kordes@uke.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Schwäbisches Kinderkrebszentrum
Contact Person Name
Michael Frühwald
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitäts klinik für Kinder- und Jugendmedizin
Contact Person Name
Ursula Holzer
Site Name
Medical Center - University Of Freiburg
Department Name
Zentrum für Kinder-und Jugendmedizin
Contact Person Name
Miriam van Buiren
Site Name
Medizinische Hochschule Hannover
Department Name
Department of Pediatric Hematology and Oncology
Contact Person Name
Martin Stanulla
Contact Person Email
Stanulla.martin@mh-hannover.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Kinderklinik und Poliklinik
Contact Person Name
Matthias Eyrich
Contact Person Email
Eyrich_M@ukw.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Division of Pediatric Oncology and Hematology
Contact Person Name
Ingrid Kühnle

Czechia

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
31-10-2024
Processing Time Days
20
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Klinika dětské hematologie a onkologie
Contact Person Name
Michal Zápotocký
Contact Person Email
michal.zapotocky@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Dětská Nemocnice, Klinika dětské onkologie
Contact Person Name
Zdeněk Pavelka
Contact Person Email
pavelka.zdenek@fnbrno.cz

Sponsor

Primary sponsor

Full Name
Day One Biopharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
- Clinical operations and site support; Ex-US RA/MoH, EC/IRB, investigator expedited and periodic safety reporting; training portal and document exchange (Firecrest); translation services via ICON Language Solutions; multiple operational duties (codes 1,2,5,6,8,11,12,15 as listed).
Name
PRA Hellas CRO A.E.
Responsibilities
- Regional CRO responsibilities including clinical operations, regulatory support and other contracted activities (codes include 1,12,2,6).
Name
PPD Development LP
Responsibilities
- Release testing and stability testing of study IMPs (tablets, powder for reconstitution).
Name
IQVIA Inc.
Responsibilities
- Safety database (Argus) hosting and management.
Name
ClinChoice
Responsibilities
- Regulatory support/QP certification and local regulatory activities (includes QP Certification – EU for SoC chemotherapy).

Third parties

  • {"country":"United States","full_name":"ClinChoice","duties_or_roles":"Codes: 10; 15 (QP Certification – EU (SoC chemotherapy))","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Myonex Limited","duties_or_roles":"15 (QP Certification – UK (SoC chemotherapy) - Investigational Labeling (SoC chemotherapy))","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"15 (Tumor specimen/slides samples storage)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"15 (Release Testing (tablets, powder for reconstitution) - Stability Testing (tablets, powder for reconstitution))","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Shanghai Syntheall Pharmaceutical Co. Ltd.","duties_or_roles":"15 (Manufacture, testing, and stability of Regulatory Starting Materials (ACTA))","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"15 (EDC Medidata Rave, contracted via ICON)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Inseption Group LLC","duties_or_roles":"11; 15 (Clinical Operations Support Resource - Trial Master File Management and Support)","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Clinical Logistics Inc.","duties_or_roles":"15 (Central lab kits management)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"15 (Medical image analysis; review - X-ray, MRI, ultrasound, etc.)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"15 (Tumor specimen/slides samples storage)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"15 (Patient travel reimbursement and travel coordinator)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Imperial Clinical Research Services International Limited","duties_or_roles":"15 (Printing services, contracted via ICON)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"14; 15 (QP release - EU (tablets, powder for reconstitution))","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Experic LLC","duties_or_roles":"15 (Packaging and Labeling (tablets, powder for reconstitution))","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q International Courier LLC","duties_or_roles":"15 (Shipping courier for laboratory samples from investigational sites to short and long term storage and testing laboratories)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"15 (IMP label translation; SmPC translations)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quotient Sciences Philadelphia LLC","duties_or_roles":"15 (Manufacturing (tablets, powder for reconstitution) -Release testing (powder for reconstitution) -Stability testing (powder for reconstitution))","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"15 (Plasma Samples analysis and storage)","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Klifo A/S","duties_or_roles":"14; 15 (QP Certification – EU (SoC chemotherapy))","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"1; 11; 12; 15; 2; 5; 6; 8 (Extensive clinical operations, regulatory and safety reporting, training and document exchange, translation services via ICON Language Solutions, Ex‑US RA/MoH, EC/IRB support; Investigator expedited and periodic safety reporting)","organisation_type":"Pharmaceutical company"}
  • {"country":"Luxembourg","full_name":"TecEx","duties_or_roles":"15 (Importer of records, contracted via ICON)","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"15 (EDC / Safety Database hosting and management)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"1; 12; 2; 6 (Clinical operations support functions)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tovorafenib
Active Substance
TOVORAFENIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Investigational (prodAuthStatus=1)
Orphan Designation
Yes
Maximum Dose
600 mg (maxDailyDoseAmount 600.00 mg)
Investigational Product Name
VINCRISIN 1 mg/ml solution injectable, 2 mg (vincristine sulfate)
Active Substance
VINCRISTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation (prodAuthStatus=2)
Maximum Dose
2 mg (maxDailyDoseAmount 2.00 mg)
Investigational Product Name
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation (prodAuthStatus=2)
Maximum Dose
1050 mg (maxDailyDoseAmount 1050.00 mg)
Investigational Product Name
VELBE 10 mg Trockensubstanz zur Injektionsbereitung / Vinblastin STADA 10 mg Pulver zur Herstellung einer Injektionslösung (vinblastine sulfate)
Active Substance
VINBLASTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation (prodAuthStatus=2)
Maximum Dose
10 mg (maxDailyDoseAmount 10.00 mg)

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