Clinical trial • Phase III • Oncology

NAPORAFENIB for NRAS-mutant cutaneous melanoma | Unresectable or metastatic cutaneous melanoma

Phase III trial of NAPORAFENIB for NRAS-mutant cutaneous melanoma | Unresectable or metastatic cutaneous melanoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
NRAS-mutant cutaneous melanoma | Unresectable or metastatic cutaneous melanoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-05-2024
First CTIS Authorization Date
16-09-2024

Trial design

Randomised, open-label, physician's choice of therapy: dacarbazine (dacarbazine medac powder for solution for infusion/injection; marketed formulations included 100 mg/200 mg/500 mg/1000 mg; maxdailydoseamount listed as 1000 mg/m2), temozolomide (temomedac hard capsules; maxdailydoseamount listed as 200 mg/m2), or trametinib monotherapy (mekinist 0.5 mg tablets; product listing shows maxdailydoseamount 2 mg).-controlled, adaptive Phase III trial in Belgium, Denmark, Sweden and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician's choice of therapy: dacarbazine (dacarbazine medac powder for solution for infusion/injection; marketed formulations included 100 mg/200 mg/500 mg/1000 mg; maxDailyDoseAmount listed as 1000 mg/m2), temozolomide (Temomedac hard capsules; maxDailyDoseAmount listed as 200 mg/m2), or trametinib monotherapy (Mekinist 0.5 mg tablets; product listing shows maxDailyDoseAmount 2 mg).
Adaptive
True - study includes a Stage 1 dose-optimization lead-in to select the optimal dose of naporafenib + trametinib (two dose regimens evaluated) prior to Stage 2; Stage 1 analyses include safety, PK and exposure-response to inform dose selection.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
178

Eligibility

Recruits 178 The trial record indicates vulnerable population selected. Participation requires the patient (age ≥ 18 years) to provide written informed consent in accordance with ICH/GCP and local regulations. Consent materials and subject information (ICFs/SIS) are provided (multiple versions/documents exist), and consent is obtained from the adult participant; no paediatric assent procedures are specified in the available record..

Pregnancy Exclusion
Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
Vulnerable Population
The trial record indicates vulnerable population selected. Participation requires the patient (age ≥ 18 years) to provide written informed consent in accordance with ICH/GCP and local regulations. Consent materials and subject information (ICFs/SIS) are provided (multiple versions/documents exist), and consent is obtained from the adult participant; no paediatric assent procedures are specified in the available record.

Inclusion criteria

  • {"criterion_text":"- Patient has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonization (ICH)/GCP guidelines and applicable local regulations\n- Age ≥ 18 years\n- Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma\n- Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory.\n- Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.\n- Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment.\n- ECOG performance status 0, 1 or 2\n- Presence of at least 1 measurable lesion according to RECIST v1.1\n- Able to swallow oral medication."}

Exclusion criteria

  • {"criterion_text":"- Patients with uveal or mucosal melanoma\n- Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor\n- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)\n- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)\n- LVEF <50%\n- Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.\n- Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study.\n- Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Stage 1 (Dose Optimization) - Analysis of the totality of the safety, pharmacokinetics (PK), and preliminary efficacy data including exposure response relationships for tolerability, safety, and efficacy from Stage 1 and throughout the naporafenib program","definition_or_measurement_approach":"Analysis of safety, PK and preliminary efficacy data including exposure-response relationships from Stage 1 and across the naporafenib program (integrated safety/PK/efficacy assessment)."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - PFS using RECIST v1.1 per blinded independent central review (BICR)","definition_or_measurement_approach":"Progression-free survival assessed using RECIST v1.1 by blinded independent central review (BICR)."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - OS","definition_or_measurement_approach":"Overall survival (OS) measured from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Stage 1 (Dose Optimization) - Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: • Objective response rate (ORR) • Disease control rate (DCR) • Duration of response (DOR) • Progression-free survival (PFS) • Time to response (TTR)","definition_or_measurement_approach":"Tumor response measures per RECIST v1.1: ORR, DCR, DOR, PFS, TTR assessed during Stage 1."}
  • {"endpoint_text":"- Stage 1 (Dose Optimization) - Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE), changes from baseline in laboratory values, vital signs, and cardiac assessments (electrocardiogram [ECG], echocardiogram [ECHO]/multigated acquisition [MUGA]) Tolerability: AEs leading to dose interruptions, reductions, and permanent discontinuation of study drug(s)","definition_or_measurement_approach":"Safety and tolerability assessed by AE/SAE incidence and severity, lab changes, vital signs, cardiac assessments (ECG, ECHO/MUGA), and AEs causing dose modifications or discontinuations."}
  • {"endpoint_text":"- Stage 1 (Dose Optimization) - Plasma concentrations of naporafenib and trametinib as combination therapy and plasma concentrations of trametinib as monotherapy obtained via sparse sampling for population PK modeling","definition_or_measurement_approach":"Sparse plasma sampling for population PK modeling to determine concentrations of naporafenib and trametinib."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - Using RECIST v1.1, per BICR: • ORR • DOR","definition_or_measurement_approach":"ORR and DOR according to RECIST v1.1 assessed by blinded independent central review."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - Safety: Incidence and severity of AEs and SAEs, changes from baseline in laboratory values, vital signs, and cardiac assessments (ECG, ECHO/ MUGA) Tolerability: AEs leading to dose interruptions, reductions, and permanent discontinuation of study drug(s)","definition_or_measurement_approach":"Safety/tolerability assessment in Stage 2 using AE/SAE incidence and severity, lab/vital sign/cardiac changes and AEs leading to dose changes or discontinuation."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - Using RECIST v1.1, per investigator assessment: • PFS • ORR • DOR • DCR • TTR","definition_or_measurement_approach":"Investigator-assessed RECIST v1.1 endpoints: PFS, ORR, DOR, DCR, TTR."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - Plasma concentrations of naporafenib and trametinib as combination therapy obtained via sparse sampling for population PK modeling","definition_or_measurement_approach":"Sparse plasma sampling for population PK modeling of combination therapy concentrations."}
  • {"endpoint_text":"- Stage 2 (Registration-Enabling Portion) - Change from baseline in: • EORTC QLQ-C30 subscales • PRO CTCAE® symptoms Change from baseline to landmark timepoint(s) for one or more of the above measures; specific endpoints of interest will be selected based on data from Stage 1 and prespecified before initiating Stage 2.","definition_or_measurement_approach":"Patient-reported outcomes: change from baseline in EORTC QLQ-C30 subscales and PRO-CTCAE symptoms at prespecified landmark timepoints."}

Recruitment

Planned Sample Size
178
Recruitment Window Months
46
Consent Approach
Written informed consent is required from each participant (Age ≥ 18 years) in accordance with ICH/GCP and local regulations. Multiple subject information sheets and ICFs are provided (documents available in multiple languages including English, French, Spanish, Dutch, German, Italian, Czech, Swedish, Norwegian, Danish). No paediatric assent procedures are specified in the available documentation.

Geography

Total Number Of Sites
76
Total Number Of Participants
178

Belgium

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Principal Investigator Name
Celine Jacobs
Principal Investigator Email
celine.jacobs@uzgent.be
Contact Person Name
Celine Jacobs
Contact Person Email
celine.jacobs@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Principal Investigator Name
Jean-François Baurain
Contact Person Name
Jean-François Baurain
Site Name
UZ Brussel
Department Name
Oncology
Principal Investigator Name
Bart Neyns
Principal Investigator Email
bart.neyns@uzbrussel.be
Contact Person Name
Bart Neyns
Contact Person Email
bart.neyns@uzbrussel.be

Denmark

Earliest CTIS Part Ii Submission Date
19-08-2024
Latest Decision Or Authorization Date
16-09-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Region Hovedstaden
Department Name
Oncology
Principal Investigator Name
Eva Ellebæk
Principal Investigator Email
eva.ellebaek.steensgaard@regionh.dk
Contact Person Name
Eva Ellebæk Steensgaard
Site Name
Aalborg University Hospital
Department Name
Oncology
Principal Investigator Name
Adam Andrzej Luczak
Principal Investigator Email
adal@rn.dk
Contact Person Name
Adam Andrzej Luczak
Contact Person Email
adal@rn.dk
Site Name
Aarhus Universitetshospital
Department Name
Oncology
Principal Investigator Name
Louise Mahncke Guldbrandt
Principal Investigator Email
louise.guldbrandt@midt.rm.dk
Contact Person Name
Louise Mahncke Guldbrandt
Contact Person Email
louise.guldbrandt@midt.rm.dk

Sweden

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
16-09-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Region Oerebro Laen
Department Name
Oncology
Principal Investigator Name
Antonis Valachis
Principal Investigator Email
antonios.valachis@oru.se
Contact Person Name
Antonis Valachis
Contact Person Email
antonios.valachis@oru.se
Site Name
Karolinska University Hospital
Department Name
Oncology
Principal Investigator Name
Lisa Villabona
Principal Investigator Email
lisa.villabona@regionstockholm.se
Contact Person Name
Lisa Villabona

Norway

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
19-09-2024
Processing Time Days
22
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Helse Stavanger HF
Department Name
Oncology
Principal Investigator Name
Israr Hussain
Principal Investigator Email
israr.hussain@sus.no
Contact Person Name
Israr Hussain
Contact Person Email
israr.hussain@sus.no
Site Name
Akershus University Hospital
Department Name
Oncology
Principal Investigator Name
Mattias Roed Underlien
Principal Investigator Email
mattias.roed-underlien@ahus.no
Contact Person Name
Mattias Roed Underlien
Contact Person Email
mattias.roed-underlien@ahus.no
Site Name
Oslo University Hospital HF
Department Name
Oncology
Principal Investigator Name
Henrik Jespersen
Principal Investigator Email
hejes@ous-hf.no
Contact Person Name
Henrik Jespersen
Contact Person Email
hejes@ous-hf.no

Czechia

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
22
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Clinical Oncology
Principal Investigator Name
Radek Lakomy
Principal Investigator Email
lakomy@mou.cz
Contact Person Name
Radek Lakomy
Contact Person Email
lakomy@mou.cz
Site Name
University Hospital Olomouc
Department Name
Oncology
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Sanatorium profesora Arenbergera
Department Name
Dermatology
Principal Investigator Name
Petr Arenberger
Principal Investigator Email
avemedica@email.cz
Contact Person Name
Petr Arenberger
Contact Person Email
avemedica@email.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Oncology and Radiotherapy
Principal Investigator Name
Jindrich Kopecky
Principal Investigator Email
jindrich.kopecky@fnhk.cz
Contact Person Name
Jindrich Kopecky
Contact Person Email
jindrich.kopecky@fnhk.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Dermatovenerology
Principal Investigator Name
Ivana Krajsova
Principal Investigator Email
ivana.krajsova@vfn.cz
Contact Person Name
Ivana Krajsova
Contact Person Email
ivana.krajsova@vfn.cz

France

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
20-09-2024
Processing Time Days
73
Number Of Sites
13
Number Of Participants
52

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Dermatology
Principal Investigator Name
Laurent Mortier
Principal Investigator Email
Laurent.mortier@chru-lille.fr
Contact Person Name
Laurent Mortier
Contact Person Email
Laurent.mortier@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Dermatology
Principal Investigator Name
Geraldine Jeudy
Principal Investigator Email
Geraldine.jeudy@chu-dijon.fr
Contact Person Name
Geraldine Jeudy
Contact Person Email
Geraldine.jeudy@chu-dijon.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Dermatology -Venerology
Principal Investigator Name
Sandrine Mansard
Principal Investigator Email
smansard@chu-clermontferrand.fr
Contact Person Name
Sandrine Mansard
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Dermatology
Principal Investigator Name
Philippe Saiag
Principal Investigator Email
Philippe.saiag@uvsq.fr
Contact Person Name
Philippe Saiag
Contact Person Email
Philippe.saiag@uvsq.fr
Site Name
Institut Gustave Roussy
Department Name
Dermatology
Principal Investigator Name
Caroline Robert
Principal Investigator Email
Caroline.robert@gustaveroussy.fr
Contact Person Name
Caroline Robert
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Dermatology
Principal Investigator Name
Eva Muñoz Consuelo
Principal Investigator Email
emunoz@vhio.net
Contact Person Name
Eva Muñoz Consuelo
Contact Person Email
emunoz@vhio.net
Site Name
Centre Hospitalier Le Mans
Department Name
Dermatology
Principal Investigator Name
Hervé Maillard
Principal Investigator Email
hmaillard@ch-lemans.fr
Contact Person Name
Hervé Maillard
Contact Person Email
hmaillard@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Dermatology
Principal Investigator Name
Jean-Matthieu L’Orphelin
Principal Investigator Email
lorphelin-jm@chu-caen.fr
Contact Person Name
Jean-Matthieu L’Orphelin
Contact Person Email
lorphelin-jm@chu-caen.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Dermatology
Principal Investigator Name
Caroline Gaudy
Principal Investigator Email
Caroline.gaudy@ap-hm.fr
Contact Person Name
Caroline Gaudy
Contact Person Email
Caroline.gaudy@ap-hm.fr
Site Name
Hospices Civils De Lyon
Department Name
Dermatology
Principal Investigator Name
Stéphane Dalle
Principal Investigator Email
Stephane.dalle@chu-Lyon.fr
Contact Person Name
Stéphane Dalle
Contact Person Email
Stephane.dalle@chu-Lyon.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Principal Investigator Name
Marc Pracht
Principal Investigator Email
m.pracht@rennes.unicancer.fr
Contact Person Name
Marc Pracht
Contact Person Email
m.pracht@rennes.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Dermatology
Principal Investigator Name
Caroline Dutriaux
Principal Investigator Email
Caroline.dutriaux@chu-bordeaux.fr
Contact Person Name
Caroline Dutriaux
Site Name
Hopital Saint Louis
Department Name
Dermatology
Principal Investigator Name
Céleste Lebbe
Principal Investigator Email
Celeste.lebbe@aphp.fr
Contact Person Name
Céleste Lebbe
Contact Person Email
Celeste.lebbe@aphp.fr

Netherlands

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
16-09-2024
Processing Time Days
19
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Oncology
Principal Investigator Name
Kalijn Bol
Principal Investigator Email
kalijn.bol@radboudumc.nl
Contact Person Name
Kalijn Bol
Contact Person Email
kalijn.bol@radboudumc.nl
Site Name
Isala Klinieken Stichting
Department Name
Oncology
Principal Investigator Name
Jan Willem De Groot
Principal Investigator Email
j.w.b.de.groot@isala.nl
Contact Person Name
Jan Willem De Groot
Contact Person Email
j.w.b.de.groot@isala.nl
Site Name
Stichting Amsterdam UMC
Department Name
Oncology
Principal Investigator Name
Alfons van den Eertwegh
Principal Investigator Email
vandeneertwegh@amsterdamumc.nl
Contact Person Name
Alfons van den Eertwegh
Contact Person Email
vandeneertwegh@amsterdamumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncology
Principal Investigator Name
Maureen Aarts
Principal Investigator Email
mjb.essers.aarts@mumc.nl
Contact Person Name
Maureen Aarts
Contact Person Email
mjb.essers.aarts@mumc.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Internal medicine
Principal Investigator Name
Bart Rikhof
Principal Investigator Email
bart.rikhof@mcl.nl
Contact Person Name
Bart Rikhof
Contact Person Email
bart.rikhof@mcl.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Oncology
Principal Investigator Name
Ellen Kapiteijn
Principal Investigator Email
h.w.kapiteijn@lumc.nl
Contact Person Name
Ellen Kapiteijn
Contact Person Email
h.w.kapiteijn@lumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncology and Radiology and Nuclear Medicine
Principal Investigator Name
Astrid van der Veldt
Principal Investigator Email
a.vanderveldt@erasmusmc.nl
Contact Person Name
Astrid van der Veldt
Contact Person Email
a.vanderveldt@erasmusmc.nl
Site Name
Medisch Centrum Leeuwarden B.V. (duplicate listing avoided)

Spain

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
16-09-2024
Processing Time Days
47
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Ainara Soria Rivas
Principal Investigator Email
ainarasoria@hotmail.com
Contact Person Name
Ainara Soria Rivas
Contact Person Email
ainarasoria@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Eva Muñoz Consuelo
Principal Investigator Email
emunoz@vhio.net
Contact Person Name
Eva Muñoz Consuelo
Contact Person Email
emunoz@vhio.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Iván Márquez Rodas
Principal Investigator Email
ivan.marquez@salud.madrid.org
Contact Person Name
Iván Márquez Rodas
Contact Person Email
ivan.marquez@salud.madrid.org
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Isabel Palacio Vázquez
Principal Investigator Email
isabel.palacio@sespa.es
Contact Person Name
Isabel Palacio Vázquez
Contact Person Email
isabel.palacio@sespa.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Juan Martin Liberal
Principal Investigator Email
jmartinliberal@iconcologia.net
Contact Person Name
Juan Martin Liberal
Contact Person Email
jmartinliberal@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Ana Arance Fernandez
Principal Investigator Email
amarance@clinic.cat
Contact Person Name
Ana Arance Fernandez
Contact Person Email
amarance@clinic.cat
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Principal Investigator Name
Delvys Rodriguez Abreu
Principal Investigator Email
delvysra@yahoo.com
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
delvysra@yahoo.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Maria Jose Juan Fita
Principal Investigator Email
mjuanfi81@hotmail.com
Contact Person Name
Maria Jose Juan Fita
Contact Person Email
mjuanfi81@hotmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Juan Francisco Rodríguez Moreno
Principal Investigator Email
jfrodriguez@hmhospitales.com
Contact Person Name
Juan Francisco Rodríguez Moreno
Contact Person Email
jfrodriguez@hmhospitales.com

Germany

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
18-09-2024
Processing Time Days
37
Number Of Sites
17
Number Of Participants
60

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Dermatology
Principal Investigator Name
Carola Berking
Principal Investigator Email
Carola.Berking@uk-erlangen.de
Contact Person Name
Carola Berking
Contact Person Email
Carola.Berking@uk-erlangen.de
Site Name
Medical Center - University Of Freiburg
Department Name
Dermatology
Principal Investigator Name
Frank Meiss
Principal Investigator Email
frank.meiss@uniklinik-freiburg.de
Contact Person Name
Frank Meiss
Site Name
Muehlenkreiskliniken AöR
Department Name
Dermatology, allergology and venerology
Principal Investigator Name
Ralf Gutzmer
Principal Investigator Email
Ralf.Gutzmer@muehlenkreiskliniken.de
Contact Person Name
Ralf Gutzmer
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Dermatology
Principal Investigator Name
Thomas Eigentler
Principal Investigator Email
thomas.eigentler@charite.de
Contact Person Name
Thomas Eigentler
Contact Person Email
thomas.eigentler@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Dermatology and allergology
Principal Investigator Name
Lucie Heinzerling
Principal Investigator Email
Lucie.Heinzerling@med.uni-muenchen.de
Contact Person Name
Lucie Heinzerling
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Dermatology
Principal Investigator Name
Thomas Tueting
Principal Investigator Email
thomas.tueting@med.ovgu.de
Contact Person Name
Thomas Tueting
Contact Person Email
thomas.tueting@med.ovgu.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Dermatology
Principal Investigator Name
Stephan Grabbe
Principal Investigator Email
Stephan.grabbe@unimedizin-mainz.de
Contact Person Name
Stephan Grabbe
Site Name
Technische Universitaet Dresden
Department Name
Dermatology
Principal Investigator Name
Friedegund Meier
Principal Investigator Email
friedegund.meier@uniklinikum-dresden.de
Contact Person Name
Friedegund Meier
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Dermatology
Principal Investigator Name
Katharina Kahler
Principal Investigator Email
kkaehler@dermatology.uni-kiel.de
Contact Person Name
Katharina Kahler
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Dermatology
Principal Investigator Name
Patrick Terheyden
Principal Investigator Email
Patrick.Terheyden@uksh.de
Contact Person Name
Patrick Terheyden
Contact Person Email
Patrick.Terheyden@uksh.de
Site Name
Universitat Heidelberg (Mannheim)
Department Name
Dermato-oncology
Principal Investigator Name
Jochen Utikal
Principal Investigator Email
j.utikal@Dkfz-Heidelberg.de
Contact Person Name
Jochen Utikal
Contact Person Email
j.utikal@Dkfz-Heidelberg.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Dermatology
Principal Investigator Name
Teresa Amaral
Principal Investigator Email
Teresa.Amaral@med.uni-tuebingen.de
Contact Person Name
Teresa Amaral
Site Name
Medizinische Hochschule Hannover
Department Name
Dermatology, allergology and venerology
Principal Investigator Name
Imke von Wasielewski
Principal Investigator Email
vonWasielewski.Imke@mh-hannover.de
Contact Person Name
Imke von Wasielewski
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Dermatology and allergology
Principal Investigator Name
Ulrich Ritter
Principal Investigator Email
ulrich.ritter@gesundheitnord.de
Contact Person Name
Ulrich Ritter
Site Name
Fachklinik Hornheide e.V.
Department Name
Oncology
Principal Investigator Name
Michael Fluck
Principal Investigator Email
Michael.Fluck@fachklinik-hornheide.de
Contact Person Name
Michael Fluck
Site Name
Universitaetsmedizin Goettingen
Department Name
Dermatology
Principal Investigator Name
Kai-Martin Thoms
Principal Investigator Email
kai.thoms@med.uni-goettingen.de
Contact Person Name
Kai-Martin Thoms
Site Name
Universitaet Leipzig
Department Name
Dermatology
Principal Investigator Name
Jan Simon
Principal Investigator Email
Jan-Christoph.Simon@medizin.uni-leipzig.de
Contact Person Name
Jan Simon

Italy

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
18-09-2024
Processing Time Days
58
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Principal Investigator Name
Vincenzo Russo
Principal Investigator Email
russo.vincenzo@hsr.it
Contact Person Name
Vincenzo Russo
Contact Person Email
russo.vincenzo@hsr.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncology
Principal Investigator Name
Alessandro Marco Minisini
Principal Investigator Email
alessandro.minisini@asufc.sanita.fvg.it
Contact Person Name
Alessandro Marco Minisini
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncology and Hematology
Principal Investigator Name
Roberta Depenni
Principal Investigator Email
depenni.roberta@policlinico.mo.it
Contact Person Name
Roberta Depenni
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncology
Principal Investigator Name
Paolo Antonio Ascierto
Principal Investigator Email
p.ascierto@istitutotumori.na.it
Contact Person Name
Paolo Antonio Ascierto
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Sarcome and rare tumor
Principal Investigator Name
Virginia Ferraresi
Principal Investigator Email
virginia.ferraresi@ifo.it
Contact Person Name
Virginia Ferraresi
Contact Person Email
virginia.ferraresi@ifo.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncology
Principal Investigator Name
Stefania Canova
Principal Investigator Email
stefania.canova@irccs-sangerardo.it
Contact Person Name
Stefania Canova
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Luisa Piccin
Principal Investigator Email
luisa.piccin@iov.veneto.it
Contact Person Name
Luisa Piccin
Contact Person Email
luisa.piccin@iov.veneto.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Rare tumours and melanoma
Principal Investigator Name
Michele Guida
Principal Investigator Email
m.guida@oncologico.bari.it
Contact Person Name
Michele Guida
Contact Person Email
m.guida@oncologico.bari.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oncology
Principal Investigator Name
Mario Mandala
Principal Investigator Email
mario.mandala@unipg.it
Contact Person Name
Mario Mandala
Contact Person Email
mario.mandala@unipg.it
Site Name
Fondazione Luigi Maria Monti
Department Name
Oncology and Dermato-Oncology
Principal Investigator Name
Paolo Marchetti
Principal Investigator Email
fondazioneluigimariamonti@legalmail.it
Contact Person Name
Paolo Marchetti
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Oncologic inmunotherapy
Principal Investigator Name
Michele Maio
Principal Investigator Email
maio@unisi.it
Contact Person Name
Michele Maio
Contact Person Email
maio@unisi.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Principal Investigator Name
Paola Queirolo
Principal Investigator Email
Paola.Queirolo@ieo.it
Contact Person Name
Paola Queirolo
Contact Person Email
Paola.Queirolo@ieo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Principal Investigator Name
Michele Del Vecchio
Principal Investigator Email
Michele.DelVecchio@istitutotumori.mi.it
Contact Person Name
Michele Del Vecchio

Sponsor

Primary sponsor

Full Name
Erasca Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Allucent (NL) B.V.
Responsibilities
clinical trial application submission; sponsor third-party handling submissions (contact SSUReg@allucent.com)

Third parties

  • {"country":"Netherlands","full_name":"Allucent (NL) B.V.","duties_or_roles":"clinical trial application submission; contact SSUReg@allucent.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Naporafenib 50mg / 75 mg / 100 mg / 200mg
Active Substance
NAPORAFENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 1 (clinical/unauthorised product listing)
Dose Levels
50 mg | 75 mg | 100 mg | 200 mg
Maximum Dose
800 mg (maxDailyDoseAmount listed)
Investigational Product Name
Mekinist (trametinib) 0.5 mg film-coated tablets
Active Substance
TRAMETINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2 (authorised product listing for Mekinist)
Dose Levels
0.5 mg tablet strength listed
Maximum Dose
2 mg (maxDailyDoseAmount listed)
Investigational Product Name
Dacarbazine medac (comparator) 100 mg / 200 mg / 500 mg / 1000 mg powder for solution for infusion/injection
Active Substance
DACARBAZINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS / INFUSION
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus 2 (authorised product listings)
Dose Levels
100 mg | 200 mg | 500 mg | 1000 mg
Maximum Dose
1000 mg/m2 (maxDailyDoseAmount listed)
Investigational Product Name
Temomedac (temozolomide) 20 mg / 100 mg hard capsules
Active Substance
TEMOZOLOMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2 (authorised product listings)
Dose Levels
20 mg | 100 mg (capsule strengths listed)
Maximum Dose
200 mg/m2 (maxDailyDoseAmount listed)
Combination Treatment
Yes

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