Clinical trial • Phase III • Oncology

Savolitinib for Papillary renal cell carcinoma (MET-driven, unresectable, locally advanced or metastatic)

Phase III trial of Savolitinib for Papillary renal cell carcinoma (MET-driven, unresectable, locally advanced or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Papillary renal cell carcinoma (MET-driven, unresectable, locally advanced or metastatic)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
14-05-2024
First CTIS Authorization Date
18-06-2024

Trial design

Randomised, open-label, savolitinib plus durvalumab versus sunitinib and durvalumab monotherapy. comparator arms include: sunitinib (sutent 12.5 mg and 25 mg hard capsules) — dose/schedule not specified in the record; durvalumab monotherapy (durvalumab intravenous) — dose/schedule not specified in the record.-controlled Phase III trial in Germany, France, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Savolitinib plus Durvalumab versus Sunitinib and Durvalumab monotherapy. Comparator arms include: Sunitinib (Sutent 12.5 mg and 25 mg hard capsules) — dose/schedule not specified in the record; Durvalumab monotherapy (Durvalumab intravenous) — dose/schedule not specified in the record.
Biomarker Stratified
True, biomarker: MET (MET-driven PRCC, centrally confirmed by sponsor-designated central laboratory validated NGS assay)
Target Sample Size
82

Eligibility

Recruits 82 adults.

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed unresectable and locally advanced or metastatic PRCC\n- PRCC must be centrally confirmed as MET-driven using a sponsor designated central laboratory validated NGS assay\n- No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting\n- Karnofsky Score ≥70\n- At least one lesion, not previously irradiated, that can be accurately measured at baseline\n- Adequate organ and bone marrow function\n- Life expectancy minimum of 12 weeks\n- Adequate coagulation parameters\n- Mandatory provision of an FFPE tumour sample to assess the MET driven PRCC"}

Exclusion criteria

  • {"criterion_text":"- History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs\n- Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention\n- Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals\n- Active infection including HIV, TB, HBV and HCV\n- Active or prior documented autoimmune or inflammatory disorders\n- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.","definition_or_measurement_approach":"Progression-free survival (PFS): time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- a. and b. : 1. OS is defined as time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"Overall survival (OS): time from randomisation until date of death due to any cause."}
  • {"endpoint_text":"- a. and b. : 2. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1.","definition_or_measurement_approach":"Objective response rate (ORR): proportion with CR or PR as determined by blinded independent central review (BICR) per RECIST 1.1."}
  • {"endpoint_text":"- a. and b. : 3. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.","definition_or_measurement_approach":"Duration of response (DoR): time from first documented response to documented progression per RECIST 1.1 by BICR or death."}
  • {"endpoint_text":"- a. and b. : 4. DCR at 24 or 48 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.","definition_or_measurement_approach":"Disease control rate (DCR) at 24/48 weeks: percentage with CR, PR, or SD per RECIST 1.1 by BICR maintained for at least 23 or 47 weeks after randomisation, respectively."}
  • {"endpoint_text":"- a. and b. : 5. PFS2 will be defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.","definition_or_measurement_approach":"PFS2: time from randomisation to earliest progression event (following initial progression) after first subsequent therapy, or death."}
  • {"endpoint_text":"- a. and b. : 6. PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.","definition_or_measurement_approach":"Progression-free survival (PFS) as above: time from randomisation until disease progression per RECIST 1.1 by BICR, or death."}
  • {"endpoint_text":"- c. Time to deterioration and change from baseline in symptoms, functioning, and HRQoL","definition_or_measurement_approach":"Patient-reported outcomes: time to deterioration and change from baseline in symptoms, functioning and health-related quality of life (HRQoL) using specified instruments."}
  • {"endpoint_text":"- d. The measures of interest are as follows: 1. participants randomised to savolitinib plus durvalumab: plasma concentration of savolitinib and its metabolites pre-dose (Ctrough) andpost-dose (C1h and C3h), serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)","definition_or_measurement_approach":"Pharmacokinetics (savolitinib + durvalumab): plasma savolitinib and metabolites pre-dose (Ctrough) and post-dose (C1h, C3h); durvalumab serum pre-dose (Ctrough) and end of infusion (Cmax)."}
  • {"endpoint_text":"- d.: 2. participants randomised to durvalumab monotherapy: serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)","definition_or_measurement_approach":"Pharmacokinetics (durvalumab monotherapy): durvalumab serum concentration pre-dose (Ctrough) and at end of infusion (Cmax)."}

Recruitment

Planned Sample Size
82
Recruitment Window Months
56
Consent Approach
Informed consent is obtained using Subject Information Sheet (SIS) and Informed Consent Form (ICF) documents (L1_SIS and ICF Main and related screening/optional forms). Optional genetic consent and a Pregnant Partner information/consent form are available. Consent materials and patient-facing documents are available in multiple country/language versions (examples in the record: CZ, ES, IT, RO, FR, DE, NL, PL). The participant provides consent; no assent/child consent process is specified in the available record.

Geography

Total Number Of Sites
55
Total Number Of Participants
62

Germany

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
601
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Klinikum der Universität München Großhadern
Department Name
Urologische Poliklinik
Principal Investigator Name
Michael Staehler
Principal Investigator Email
michael.staehler@med.uni-muenchen.de
Contact Person Name
Michael Staehler
Site Name
Medizinische Hochschule Hannover
Department Name
Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Philipp Ivanyi
Principal Investigator Email
Ivanyi.Philipp@mh-hannover.de
Contact Person Name
Philipp Ivanyi
Contact Person Email
Ivanyi.Philipp@mh-hannover.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Urology
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
Friedemann.zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Urologie (Studienzentale)
Principal Investigator Name
Steffen Rausch
Principal Investigator Email
steffen.rausch@med.uni-tuebingen.de
Contact Person Name
Steffen Rausch
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Urology
Principal Investigator Name
Victor Schüttfort
Principal Investigator Email
v.schuettfort@uke.de
Contact Person Name
Victor Schüttfort
Contact Person Email
v.schuettfort@uke.de

France

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
581
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'Oncologie Médicale
Principal Investigator Name
Marine Gross-Goupil
Principal Investigator Email
marine.gross-goupil@chu-bordeaux.fr
Contact Person Name
Marine Gross-Goupil
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Oncology
Principal Investigator Name
Josselin Annic
Principal Investigator Email
Josselin.annic@ch-cornouaille.fr
Contact Person Name
Josselin Annic
Site Name
Institut Gustave Roussy
Principal Investigator Name
Laurence Albiges
Principal Investigator Email
laurence.albiges@gustaveroussy.fr
Contact Person Name
Laurence Albiges

Spain

Earliest CTIS Part Ii Submission Date
18-06-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
605
Number Of Sites
19
Number Of Participants
19

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Begoña Perez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Perez Valderrama
Contact Person Email
bpvalderrama@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Aurea Molina Diaz
Principal Investigator Email
Aurea.Molina.Diaz@sergas.es
Contact Person Name
Aurea Molina Diaz
Contact Person Email
Aurea.Molina.Diaz@sergas.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Aranzazu Gonzalez del Alba
Principal Investigator Email
aranzazu.gonzalezdelalba@ssib.es
Contact Person Name
Aranzazu Gonzalez del Alba
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Oscar Reig Torras
Principal Investigator Email
oreig@clinic.cat
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Javier Molina-Cerrillo
Principal Investigator Email
javier.molinace@gmail.com
Contact Person Name
Javier Molina-Cerrillo
Contact Person Email
javier.molinace@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Regina Girones Sarrio
Principal Investigator Email
girones_reg@gva.es
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Cristina Suarez-Rodriguez
Principal Investigator Email
crsuarez@vhebron.net
Contact Person Name
Cristina Suarez-Rodriguez
Contact Person Email
crsuarez@vhebron.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Nuria Lainez-Milagro
Principal Investigator Email
nuria.lainez.milagro@cfnavarra.es
Contact Person Name
Nuria Lainez-Milagro
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Maria Jose Méndez Vidal
Principal Investigator Email
mjosemv@yahoo.es
Contact Person Name
Maria Jose Méndez Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Javier Puente Vazquez
Principal Investigator Email
javierpuente.hcsc@gmail.com
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Lucia Oliva Fernandez
Principal Investigator Email
luciaolifer3@gmail.com
Contact Person Name
Lucia Oliva Fernandez
Contact Person Email
luciaolifer3@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Jose Maroto Rey
Principal Investigator Email
jmaroto@santpau.cat
Contact Person Name
Jose Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Guillermo de Velasco Oria de Rueda
Principal Investigator Email
gdvelasco.gdv@gmail.com
Contact Person Name
Guillermo de Velasco Oria de Rueda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda (duplicate listing if present)
Department Name
Oncology
Principal Investigator Name
Aranzazu Gonzalez del Alba
Principal Investigator Email
aranzazu.gonzalezdelalba@ssib.es
Contact Person Name
Aranzazu Gonzalez del Alba
Site Name
Hospital Universitario Virgen Del Rocio S.L. (additional listed sites may repeat)
Department Name
Oncology
Principal Investigator Name
Begoña Perez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Perez Valderrama
Contact Person Email
bpvalderrama@gmail.com
Site Name
Hospital Universitario Reina Sofia (additional listed entries may repeat)
Department Name
Oncology
Principal Investigator Name
Maria Jose Méndez Vidal
Principal Investigator Email
mjosemv@yahoo.es
Contact Person Name
Maria Jose Méndez Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Universitario De Navarra (additional listed entries may repeat)
Department Name
Oncology
Principal Investigator Name
Nuria Lainez-Milagro
Principal Investigator Email
nuria.lainez.milagro@cfnavarra.es
Contact Person Name
Nuria Lainez-Milagro
Site Name
Hospital Universitario Y Politecnico La Fe (additional listed entries may repeat)
Department Name
Oncology
Principal Investigator Name
Regina Girones Sarrio
Principal Investigator Email
girones_reg@gva.es
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es

Netherlands

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
602
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Oncology, Cancer Immunology
Principal Investigator Name
Adriaan Bins
Principal Investigator Email
a.d.bins@amsterdamumc.nl
Contact Person Name
Adriaan Bins
Contact Person Email
a.d.bins@amsterdamumc.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Oncology
Principal Investigator Name
Aart-Paul Hamberg
Principal Investigator Email
p.hamberg@franciscus.nl
Contact Person Name
Aart-Paul Hamberg
Contact Person Email
p.hamberg@franciscus.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Oncology
Principal Investigator Name
Theo Van Voorthuizen
Principal Investigator Email
tvanvoorthuizen@rijnstate.nl
Contact Person Name
Theo Van Voorthuizen
Contact Person Email
tvanvoorthuizen@rijnstate.nl

Poland

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
579
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Clinical oncology
Principal Investigator Name
Cezary Szczylik
Principal Investigator Email
cszczylik@wp.pl
Contact Person Name
Cezary Szczylik
Contact Person Email
cszczylik@wp.pl
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Department Name
Oncology
Principal Investigator Name
Wojciech Piskorski
Principal Investigator Email
piskorski@tlen.pl
Contact Person Name
Wojciech Piskorski
Contact Person Email
piskorski@tlen.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oncology
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
piotr.tomczak@oncology.am.poznan.pl
Contact Person Name
Piotr Tomczak
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Clinical Oncology "One- Day" Treatment
Principal Investigator Name
Joanna Pikiel
Principal Investigator Email
joanna.pikiel@post.pl
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology
Principal Investigator Name
Renata Zaucha
Principal Investigator Email
renata.zaucha@gmail.com
Contact Person Name
Renata Zaucha
Contact Person Email
renata.zaucha@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
595
Number Of Sites
11
Number Of Participants
10

Sites

Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia Medica 1
Principal Investigator Name
Davide Bimbatti
Principal Investigator Email
davide.bimbatti@iov.veneto.it
Contact Person Name
Davide Bimbatti
Contact Person Email
davide.bimbatti@iov.veneto.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
UOC Oncologia
Principal Investigator Name
Emanuela Fantinel
Principal Investigator Email
emanuela.fantinel@aovr.veneto.it
Contact Person Name
Emanuela Fantinel
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Oncologia
Principal Investigator Name
Ferdinando Riccardi
Principal Investigator Email
ferdinando.riccardi@aocardarelli.it
Contact Person Name
Ferdinando Riccardi
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
UOC Oncologia Medica
Principal Investigator Name
Cristina Masini
Principal Investigator Email
cristina.masini@ausl.re.it
Contact Person Name
Cristina Masini
Contact Person Email
cristina.masini@ausl.re.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Cristian Lolli
Principal Investigator Email
cristian.lolli@irst.emr.it
Contact Person Name
Cristian Lolli
Contact Person Email
cristian.lolli@irst.emr.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncologia Medica e Translazionale
Principal Investigator Name
Annalisa Guida
Principal Investigator Email
a.guida@aospterni.it
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Oncologia Medica
Principal Investigator Name
Francesco Massari
Principal Investigator Email
francesco.massari@aosp.bo.it
Contact Person Name
Francesco Massari
Contact Person Email
francesco.massari@aosp.bo.it
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@gmail.com
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com
Site Name
University Hospital Consorziale Policlinico
Department Name
UOC Oncologia
Principal Investigator Name
Camillo Porta
Principal Investigator Email
camillo.porta@gmail.com
Contact Person Name
Camillo Porta
Contact Person Email
camillo.porta@gmail.com
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
UOC Oncologia
Principal Investigator Name
Emiliano Tamburini
Principal Investigator Email
emilianotamburini@icloud.com
Contact Person Name
Emiliano Tamburini
Contact Person Email
emilianotamburini@icloud.com

Romania

Earliest CTIS Part Ii Submission Date
26-06-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
600
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Radiotherapy
Principal Investigator Name
Cristina Ligia Cebotaru
Principal Investigator Email
cristinacebotaru@yahoo.com
Contact Person Name
Cristina Ligia Cebotaru
Contact Person Email
cristinacebotaru@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
Oncology
Principal Investigator Name
Anghel Adrian Udrea
Principal Investigator Email
adrianudrea@medisprof.ro
Contact Person Name
Anghel Adrian Udrea
Contact Person Email
adrianudrea@medisprof.ro

Czechia

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
602
Number Of Sites
7
Number Of Participants
6

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika onkologie
Principal Investigator Name
Kateřina Kopečková
Principal Investigator Email
katerina.kopeckova@fnmotol.cz
Contact Person Name
Kateřina Kopečková
Contact Person Email
katerina.kopeckova@fnmotol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Radiologická a onkologická klinika
Principal Investigator Name
Jan Dvořák
Principal Investigator Email
jan.dvorak@fnkv.cz
Contact Person Name
Jan Dvořák
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1.LF UK a TN
Principal Investigator Name
Aneta Rozsypalová
Principal Investigator Email
aneta.rozsypalova@ftn.cz
Contact Person Name
Aneta Rozsypalová
Contact Person Email
aneta.rozsypalova@ftn.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Institut radiační onkologie
Principal Investigator Name
Petra Holečková
Principal Investigator Email
petra.holeckova@bulovka.cz
Contact Person Name
Petra Holečková
Contact Person Email
petra.holeckova@bulovka.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Principal Investigator Name
Jindřich Kopecký
Principal Investigator Email
jindrich.kopecky@fnhk.cz
Contact Person Name
Jindřich Kopecký
Contact Person Email
jindrich.kopecky@fnhk.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Principal Investigator Name
Zdeněk Král
Principal Investigator Email
kral.zdenek@fnbrno.cz
Contact Person Name
Zdeněk Král
Contact Person Email
kral.zdenek@fnbrno.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Fortrea Inc.
Responsibilities
Monitoring - Regulatory (e.g. preparation, of applicatios to CA and EC); Investigator recruitment; Data management; SUSAR reporting; Quality assurance auditing; Statistical analysis; Medical writing; Project Management
Name
Clario
Responsibilities
ePRO
Name
Signant Health Global LLC
Responsibilities
IVRS - Treatment Randomisation
Name
Axio
Responsibilities
IDMC
Name
Perceptive Informatics Inc.
Responsibilities
- Medical image analysis/ review - X-ray, MRI, ultrasound, etc.; Primary/ surrogate endpoint test
Name
Data GC Solutions Ltd
Responsibilities
Monitoring; Quality Control of FMI data

Third parties

  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Monitoring - Regulatory (e.g. preparation, of applicatios to CA and EC); Investigator recruitment; Data management; SUSAR reporting; Quality assurance auditing; Statistical analysis; Medical writing; Project Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"ePRO","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"- Medical image analysis/ review - X-ray, MRI, ultrasound, etc.; Primary/ surrogate endpoint test","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Data GC Solutions Ltd","duties_or_roles":"Monitoring; Quality Control of FMI data","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Histopathology","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Thank you card, patient facing documents","organisation_type":"Patient organisation/association"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Assessment of PD-L1 expression status","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS - Treatment Randomisation","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Axio","duties_or_roles":"IDMC","organisation_type":"Industry"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Bioanalytical Services LLC","duties_or_roles":"PK Savolitinib","organisation_type":"Industry"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Samples management and storage + HLA subtype and CHIP mutation analysis + LFT (home visit)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Savolitinib
Active Substance
Savolitinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1 (PRD10842506)
Maximum Dose
600 mg (maxDailyDoseAmount: 600)
Investigational Product Name
Durvalumab
Active Substance
Durvalumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus: 2 (SUB176342)
Maximum Dose
1500 mg (maxDailyDoseAmount: 1500)
Combination Treatment
Yes

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