Clinical trial • Phase II/III • Oncology

N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Recurrent or metastatic head and neck squamous cell carcinoma

Phase II/III trial of N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Recurrent or meta…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent or metastatic head and neck squamous cell carcinoma
Trial Stage
Phase II/III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-12-2023
First CTIS Authorization Date
16-04-2024

Trial design

Randomised, pembrolizumab 200 mg intravenously (iv) every 3 weeks (±2 days) plus xl092-matched placebo (oral, once daily) as control arm; note protocol amendment: placebo not required as of protocol amendment 4., adaptive Phase II/III trial in Hungary, Germany, Czechia and others.

Randomised
Yes
Comparator
Pembrolizumab 200 mg intravenously (IV) every 3 weeks (±2 days) plus XL092-matched placebo (oral, once daily) as control arm; note protocol amendment: placebo not required as of Protocol Amendment 4.
Adaptive
True, interim Go/No-Go analysis: Phase 2 planned ~250 subjects with analysis to determine progression to Phase 3 triggered after 90 PFS events in the first ~150 randomized subjects; protocol amendments included dose reduction guidance (100 mg qd reduced to 40 mg qd per Protocol Amendment 4) and Sponsor review of unblinded data resulting in decision not to proceed to Phase 3.
Target Sample Size
250

Eligibility

Recruits 250 The trial record indicates 'isVulnerablePopulationSelected': true. Participants must be adults (Age 18 years or older or legal age of consent in the country). Informed consent is to be obtained from the participant (adult) using the provided ICF documents; country-specific ICFs and participant information materials are provided (multiple language versions). No details on assent for minors are provided (minors are excluded by age criteria)..

Pregnancy Exclusion
Pregnant or lactating females.
Vulnerable Population
The trial record indicates 'isVulnerablePopulationSelected': true. Participants must be adults (Age 18 years or older or legal age of consent in the country). Informed consent is to be obtained from the participant (adult) using the provided ICF documents; country-specific ICFs and participant information materials are provided (multiple language versions). No details on assent for minors are provided (minors are excluded by age criteria).

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy Note: Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed. Note: The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx."}
  • {"criterion_text":"- PD-L1 expression level Combined Positive Score (CPS) ≥ 1"}
  • {"criterion_text":"- Subjects with oropharynx cancer must have assessment of HPV status from tumor tissue, per p16 testing."}
  • {"criterion_text":"- Measurable disease according to RECIST 1.1 determined by the Investigator."}
  • {"criterion_text":"- Recovery to baseline or ≤ Grade 1 severity(CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) is clinically nonsignificant and/or stable on supportive therapy."}
  • {"criterion_text":"- Age 18 years (or the legal age of consent in your country, if higher than 18) or older on the day of consent."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 ; with documented assessment of independent activities of daily living (ADLs) and physical activity, as appropriate and according to subject’s age."}
  • {"criterion_text":"- Adequate organ and marrow function"}
  • {"criterion_text":"- (implicit) Subjects: Patients"}

Exclusion criteria

  • {"criterion_text":"- Nasopharynx, salivary gland or occult primary site (regardless of p16 status)"}
  • {"criterion_text":"- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization."}
  • {"criterion_text":"- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 28 days before randomization."}
  • {"criterion_text":"- Pregnant or lactating females."}
  • {"criterion_text":"- Administration of a live, attenuated vaccine within 30 days before randomization."}
  • {"criterion_text":"- Has disease that is suitable for local therapy administered with curative intent"}
  • {"criterion_text":"- Has received prior systemic immunotherapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137), except for anti-PD-1 or anti-PD-L1 agents in the peri-operative setting if progression/recurrence occurred ≥12 months after its completion."}
  • {"criterion_text":"- Life expectancy < 3 months and/or a rapidly progressing disease (eg, uncontrolled tumor pain), which should be reviewed in the context of prior systemic therapy in the curative setting and must be discussed with the Sponsor."}
  • {"criterion_text":"- Had documented progressive disease within less than 6 months of completion of either curatively or palliatively intended systemic treatment (ie, chemotherapy) for HNSCC, in locally advanced HNSCC or peri-operative setting. Note: radiographic confirmation of progressive disease is required. If both histologic and radiographic confirmations are available, the earliest date should be considered for documentation purposes. Subjects who progressed within 6 months of systemic treatment in non-curative setting are also excluded."}
  • {"criterion_text":"- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy, such as radiation pneumonitis or fistulation, are not eligible"}
  • {"criterion_text":"- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization"}
  • {"criterion_text":"- Positive hepatitis B surface antigen (HBsAg) test."}
  • {"criterion_text":"- Positive hepatitis C virus (HCV) antibody test"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator","definition_or_measurement_approach":"Progression-free survival (PFS) assessed per RECIST 1.1 as determined by the Investigator"}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of AEs, SAEs, AECIs","definition_or_measurement_approach":"Adverse events, serious adverse events and adverse events of clinical interest recorded and graded (CTCAE)"}
  • {"endpoint_text":"- Changes in laboratory parameters and vital signs","definition_or_measurement_approach":"Laboratory tests and vital signs measured over time per protocol schedule"}
  • {"endpoint_text":"- ORR and DOR per RECIST 1.1 by Investigator","definition_or_measurement_approach":"Objective response rate and duration of response assessed by RECIST 1.1 by Investigator"}
  • {"endpoint_text":"- Plasma concentration of zanzalintinib","definition_or_measurement_approach":"Pharmacokinetic measurement of zanzalintinib plasma concentrations"}
  • {"endpoint_text":"- Correlation measured between pharmacokinetics of zanzalintinib and selected biomarkers with respect to preliminary safety and efficacy outcomes","definition_or_measurement_approach":"Correlation analyses between PK parameters and selected biomarkers vs safety/efficacy outcomes"}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS)"}

Recruitment

Digital Remote Recruitment
True, methods include study websites, paid search/SEM, banner ads, email blasts to HCPs, online HCP materials, and WhatsApp materials as documented in recruitment materials; these are provided in country-specific packages.
Planned Sample Size
250
Recruitment Window Months
61
Consent Approach
Informed consent is obtained from the participant (adults aged ≥18 years or the legal age of consent in the country). Country-specific Subject Information Sheets and Informed Consent Forms are provided (multiple language versions and country-specific ICFs listed in the documents); there are also Pregnant Partner ICFs and ancillary ICFs (e.g., optional biomarker, PGx). No procedures for assent of minors are provided (minors are excluded).

Methods

  • Doctor-to-Patient letters (DTP Recruitment Letter) sent to potential patients via physicians (country-specific DTP letters listed in recruitment materials).
  • DTP Recruitment Flyer and Patient Recruitment Brochure / Patient Study Guide distributed to patients.
  • HCP recruitment materials: HCP Recruitment Brochures, Posters, Leaflets, Physician Referral Letters to engage clinicians.
  • Digital channels: study websites and HCP websites (country-specific website materials), paid search / SEM and online banner advertisements targeted to HCPs and/or patients.
  • Email outreach to HCPs (HCP Email / Email blast) and targeted HCP communications (Talking Points Guide).
  • Printed site materials: Site Reminder Clings, Postcards, HCP Postcards, and on-site flyers.
  • Patient-facing ID cards and Patient Study Guides provided to enrolled participants.
  • Messaging channels: WhatsApp materials referenced in country recruitment package (Italy materials include WhatsApp leaflet).
  • Country-specific tailored recruitment kits and materials (multiple country-localised versions of the above materials are provided).

Geography

Total Number Of Sites
66
Total Number Of Participants
112

Hungary

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
17-04-2025
Processing Time Days
385
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Fej-Nyaki Daganatok Multidiszciplinális Központ
Contact Person Name
Pintér Tamás
Contact Person Email
pinter.tamas@oncol.hu
Site Name
Szent Lazar Megyei Korhaz
Department Name
Onkológia és Sugárterápiás Osztály
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
Semmelweis University
Department Name
Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinika
Contact Person Name
László Tamás
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Onkológiai Osztály
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yousuf@tmkorhaz.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiologiai Kozpont
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu

Germany

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
405
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Hals-, Nasen-. Ohrenheilkunde/Plastische Operationen
Contact Person Name
Andreas Dietz
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik und Poliklinik Hämatologie und Medizinische Onkologie
Contact Person Name
Jürgen Alt
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Benjamin Franklin, Med. Klinik m.S. Haematologie, Onkologie
Contact Person Name
Konrad Klinghammer
Contact Person Email
konrad.klinghammer@charite.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Hämatologie und internistische Onkologie, Innere Medizin, Zusatzbezeichnung Palliativmedizin
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Hals- Nasen- und Ohrenklinik
Contact Person Name
Christine Langer
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, OE 6860
Contact Person Name
Phillip Ivanyi
Contact Person Email
Ivanyi.Philipp@mh-hannover.de

Czechia

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
759
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Oncology Department
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
University Hospital Olomouc
Department Name
Oncology clinic
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.Melichar@fnol.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oncology clinic
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Complex Oncology Center
Contact Person Name
Marcel Matzenauer
Contact Person Email
marcel.matzenauer@nnj.agel.cz

Greece

Earliest CTIS Part Ii Submission Date
10-01-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
432
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Department of Medical Oncology, Aristotle University of Thessaloniki
Contact Person Name
Georgios Lazaridis
Contact Person Email
georlaz@yahoo.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Department of Internal Medicine - Propaedeutic
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Bioclinic S.A.
Department Name
Oncology Department
Contact Person Name
Ioannis Boukovinas
Contact Person Email
ibouk@otenet.gr

Italy

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
733
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Alessandra Cassano
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Medical Oncology
Contact Person Name
Hector Josè Soto Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Operating unit of Oncology and Hematology
Contact Person Name
Paolo Bossi
Contact Person Email
paolo.bossi@hunimed.eu
Site Name
European Institute Of Oncology S.r.l.
Department Name
Strategic Research Program on Chronic Lymphocytic Leukemia, Division of Experimental Oncology
Contact Person Name
Maria Cossu Rocca
Contact Person Email
Maria.cossurocca@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Medical Oncology Unit
Contact Person Name
Andrea Alberti
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology
Contact Person Name
Andrea Zivi
Contact Person Email
Andrea.zivi@aovr.veneto.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncology
Contact Person Name
Vanessa Gregorc
Contact Person Email
vanessa.gregorc@ircc.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C Oncologia Clinica Sperimentale Testa-Collo e Muscolo-Scheletrica
Contact Person Name
Francesco Perri
Contact Person Email
f.perri@istitutotumori.na.it

Belgium

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
734
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical oncology
Contact Person Name
Jean-Pascal Machiels
Site Name
Grand Hopital De Charleroi
Department Name
Medical Oncology
Contact Person Name
Christophe Lonchay
Contact Person Email
Christophe.lonchay@ghdc.be
Site Name
Vitaz
Department Name
Medical Oncology
Contact Person Name
Willem Lybaert
Contact Person Email
Willem.Lybaert@vitaz.be
Site Name
Hopital De Libramont
Department Name
Medical Oncology
Contact Person Name
Frédéric Forget
Contact Person Email
frederic.forget@vivalia.be
Site Name
Grand Hopital De Charleroi
Department Name
Medical oncology
Contact Person Name
Aurélie Louvet
Contact Person Email
aurelie.louvet@ghdc.be

Spain

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
728
Number Of Sites
7
Number Of Participants
9

Sites

Site Name
Hospital Universitario La Paz
Department Name
oncology
Contact Person Name
Beatriz Castelo Fernandez
Contact Person Email
castelobeatriz@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
oncology
Contact Person Name
Maria Aguado Sorolla
Contact Person Email
MAguadoS@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
oncology
Contact Person Name
Ainara Soria Rivas
Contact Person Email
ainarasoria@hotmail.com
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
oncology
Contact Person Name
Ana Medina Colmenero
Contact Person Email
ana.medina@cog.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
oncology
Contact Person Name
Teresa Garcia Manrique
Contact Person Email
tgarciamanrique@gmail.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
oncology
Contact Person Name
Javier Martinez Trufero
Contact Person Email
jmtrufero@seom.org
Site Name
Hospital Universitario Ramon Y Cajal (additional listing)
Department Name
oncology

Austria

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
727
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Department of ERT, Head and Neck surgery
Contact Person Name
Maximilian Hartl

Poland

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
732
Number Of Sites
6
Number Of Participants
3

Sites

Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Contact Person Name
Michał Masłowski
Contact Person Email
maslowskimichal@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Contact Person Name
Tomasz Rutkowski
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Chemioterapii Nowotworów
Contact Person Name
Piotr Sawrycki
Contact Person Email
piotrsaw@am.torun.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Contact Person Name
Izabella Dębicka
Contact Person Email
izabella.debicka@dcopih.pl

Slovakia

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
727
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Fakultna Nemocnica Trnava
Department Name
Onkologicka klinika
Contact Person Name
Marian Stresko
Contact Person Email
marian.stresko@fntt.sk
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Oddelenie klinickej onkologie
Contact Person Name
Pavol Dubinsky
Contact Person Email
dubinsky@vou.sk

France

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
342
Number Of Sites
11
Number Of Participants
7

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Aurore Vozy
Contact Person Email
aurore.vozy@aphp.fr
Site Name
Hospital La Croix Rousse Hcl
Department Name
Medical Oncology
Contact Person Name
Amandine BRUYAS
Contact Person Email
amandine.bruyas@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Medical Oncology
Contact Person Name
Matthieu BAINAUD
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology
Contact Person Name
Aurélie LAGRANGE
Contact Person Email
alagrange@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Contact Person Name
Amaury Daste
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Jerome Fayette
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Medical Oncology
Contact Person Name
Sebastien Salas
Contact Person Email
sebastien.salas@ap-hm.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Medical Oncology
Contact Person Name
Julien PAVILLET
Contact Person Email
JPavillet@chu-grenoble.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Cyril ABDEDDAIM
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Contact Person Name
Florian Estrade
Contact Person Email
f.estrade@rennes.unicancer.fr
Site Name
Additional listed French site
Department Name
Medical Oncology

Bulgaria

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
678
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Department of Medical Oncology
Contact Person Name
Kremena Vasileva
Contact Person Email
kre.ivanova@abv.bg
Site Name
Complex Oncology Center Ruse EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Valeriy Yordanov
Contact Person Email
dr_vjordanov@abv.bg

Romania

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
807
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Oncologie
Contact Person Name
Cristina Marinela Oprean
Contact Person Email
coprean@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
Oncologie
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie Medicala
Contact Person Name
Amedeia-Lavinia Nita
Contact Person Email
amedeianita@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Andrei Ungureanu
Site Name
Policlinica CCBR S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Aurelia Alexandru
Contact Person Email
auraalexandru@yahoo.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
Medical monitoring, Ethics submissions, IP supply (manage import licenses, reconciliation, destruction) and other operational responsibilities as listed
Name
Voiant LLC
Responsibilities
Imaging
Name
Medidata Solutions Inc.
Responsibilities
Electronic data capture/study data systems

Third parties

  • {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Medical monitoring, Ethics submissions, IP supply (manage import licenses, reconciliation, destruction) and multiple operational roles (codes listed in registry)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Laboratory services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Assaygate Inc.","duties_or_roles":"Assay services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ECG services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Laboratory services","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Various operational roles (codes listed) including ethics and local operational support","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Clinical data systems (product role code 7)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"Patient Reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Resolian Bioanalytics","duties_or_roles":"Bioanalytical laboratory services","organisation_type":"Industry"}

Investigational products

Investigational Product Name
XL092
Active Substance
N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Not authorised (prodAuthStatus=1)
Starting Dose
100 mg orally once daily (reduced to 40 mg once daily as of Protocol Amendment 4)
Dose Levels
100 mg once daily; 40 mg once daily (per Protocol Amendment 4)
Frequency
Once daily (qd)
Maximum Dose
100 mg (maxDailyDoseAmount=100 mg)
Investigational Product Name
KEYTRUDA (pembrolizumab)
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/15/1024/002)
Starting Dose
200 mg IV every 3 weeks (±2 days)
Dose Levels
200 mg IV q3w
Frequency
Every 3 weeks (q3w)
Maximum Dose
200 mg (maxDailyDoseAmount=200 mg)
Combination Treatment
Yes

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