Clinical trial • Phase III • Oncology
N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Metastatic colorectal cancer
Phase III trial of N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Metastatic colorecta…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic colorectal cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 08-07-2024
- First CTIS Authorization Date
- 31-07-2024
Trial design
Randomised, open-label, xl092 + atezolizumab versus regorafenib (stivarga 40 mg film-coated tablets); dosing/schedule not specified in the ctis record-controlled Phase III trial in France, Spain, Portugal and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- XL092 + atezolizumab versus Regorafenib (Stivarga 40 mg film-coated tablets); dosing/schedule not specified in the CTIS record
- Biomarker Stratified
- True, biomarker: MSI status (MSS/MSI-low); strata: NLM (subjects without liver metastases) subgroup specified
- Target Sample Size
- 616
Eligibility
Recruits 616 Vulnerable population selected. Inclusion requires: "Capable of understanding and complying with the protocol requirements and must have signed the informed consent document." Informed consent documents available in multiple languages (multiple national ICFs listed). No paediatric consent/assent procedures described; minimum age is 18 years..
- Pregnancy Exclusion
- Pregnant or lactating females.
- Vulnerable Population
- Vulnerable population selected. Inclusion requires: "Capable of understanding and complying with the protocol requirements and must have signed the informed consent document." Informed consent documents available in multiple languages (multiple national ICFs listed). No paediatric consent/assent procedures described; minimum age is 18 years.
Inclusion criteria
- {"criterion_text":"- Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum"}
- {"criterion_text":"- Has received the following SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies. Prior investigational therapies are allowed."}
- {"criterion_text":"- Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al 2009) as determined by the Investigator."}
- {"criterion_text":"- Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization."}
- {"criterion_text":"- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from AEs related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy"}
- {"criterion_text":"- Age 18 years or older on the day of consent."}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1."}
- {"criterion_text":"- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 10 days before randomization."}
- {"criterion_text":"- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document."}
- {"criterion_text":"- Fertile subjects and their partners must agree to use highly effective methods of contraception (defined in Appendix H) during the course of the study and for the following durations after the last dose of treatment (whichever is later)"}
- {"criterion_text":"- Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of consecutive amenorrhea in a female > 45 years-of-age in the absence of other biological or physiological causes. In addition, females < 55 years-of-age must have a serum follicle-stimulating hormone [FSH] level > 40 mIU/mL to confirm menopause)."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting ICIs."}
- {"criterion_text":"- Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization."}
- {"criterion_text":"- Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anticancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization."}
- {"criterion_text":"- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy 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 before randomization."}
- {"criterion_text":"- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: (please refer to the protocol)"}
- {"criterion_text":"- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization."}
- {"criterion_text":"- Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization."}
- {"criterion_text":"- Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization per electrocardiogram (ECG) before randomization (see Section 5.7.4 for Fridericia formula)."}
- {"criterion_text":"- Previously identified allergy or hypersensitivity to components of the study treatment formulations."}
- {"criterion_text":"- Any other active malignancy or diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6."}
- {"criterion_text":"- Administration of a live, attenuated vaccine within 30 days before randomization."}
- {"criterion_text":"- Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug (eg, PEG tube)."}
- {"criterion_text":"- History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent."}
- {"criterion_text":"- Pregnant or lactating females."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- PFS as assessed by the investigator per RECIST 1.1, ORR as assessed by the investigator per RECIST 1.1, DOR as assessed by the investigator per RECIST 1.1","definition_or_measurement_approach":"Assessed by the investigator per RECIST 1.1"}
- {"endpoint_text":"- Incidence and severity of Es, SAEs and adverse events of special interest (AESIs)","definition_or_measurement_approach":"Incidence and severity reporting of AEs, SAEs and AESIs (safety assessment)"}
- {"endpoint_text":"- Plasma concentration of XL092 given in combination with atezolizumab, serum concentration of atezolizumab given in combination with XL092, the incidence of antidrug antibody (ADA) response against atezolizumab given in combination with XL092.","definition_or_measurement_approach":"Pharmacokinetic measurements of plasma/serum concentrations; immunogenicity assessed by incidence of ADA"}
Recruitment
- Planned Sample Size
- 616
- Recruitment Window Months
- 34
- Consent Approach
- Participants must provide written informed consent. Inclusion requires 'Age 18 years or older on the day of consent' and 'Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.' Subject information and informed consent forms are available in multiple country-specific languages (examples in CTIS: French, Spanish, Portuguese, Polish, Hungarian, German, Dutch, Portuguese). No paediatric assent procedures are described.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 328
France
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 52
- Number Of Sites
- 7
- Number Of Participants
- 70
Sites
- Site Name
- Hopital Prive Jean Mermoz
- Department Name
- Oncology department
- Principal Investigator Name
- Pascal Artru
- Principal Investigator Email
- dr.artru@wanadoo.fr
- Contact Person Name
- Pascal Artru
- Contact Person Email
- dr.artru@wanadoo.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Medical Oncology department
- Principal Investigator Name
- Thibault Mazard
- Principal Investigator Email
- thibault.mazard@icm.unicancer.fr
- Contact Person Name
- Thibault Mazard
- Contact Person Email
- thibault.mazard@icm.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Digestive oncology Hepatogastroenterology Department
- Principal Investigator Name
- Laetitia Dahan
- Principal Investigator Email
- laetitia.dahan@ap-hm.fr
- Contact Person Name
- Laetitia Dahan
- Contact Person Email
- laetitia.dahan@ap-hm.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncology Department
- Principal Investigator Name
- Christophe Borg
- Principal Investigator Email
- Xtoph.borg@gmail.com
- Contact Person Name
- Christophe Borg
- Contact Person Email
- Xtoph.borg@gmail.com
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology department
- Principal Investigator Name
- François Ghiringhelli
- Principal Investigator Email
- Fghiringhelli@cgfl.fr
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- Fghiringhelli@cgfl.fr
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- Oncology department
- Principal Investigator Name
- Olivier Dubreuil
- Principal Investigator Email
- odubreuil@hopital-dcss.org
- Contact Person Name
- Olivier Dubreuil
- Contact Person Email
- odubreuil@hopital-dcss.org
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology department
- Principal Investigator Name
- Asmahane Benmaziane
- Principal Investigator Email
- a.benmaziane@hopital-foch.com
- Contact Person Name
- Asmahane Benmaziane
- Contact Person Email
- a.benmaziane@hopital-foch.com
Spain
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 1
- Number Of Sites
- 10
- Number Of Participants
- 54
Sites
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonieta Salud Salvia
- Principal Investigator Email
- masalud.lleida.ics@gencat.cat
- Contact Person Name
- Antonieta Salud Salvia
- Contact Person Email
- masalud.lleida.ics@gencat.cat
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Cubillo Gracian
- Principal Investigator Email
- acubillo@hmhospitales.com
- Contact Person Name
- Antonio Cubillo Gracian
- Contact Person Email
- acubillo@hmhospitales.com
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Vicente Alonso Orduña
- Principal Investigator Email
- valonsoo@salud.aragon.es
- Contact Person Name
- Vicente Alonso Orduña
- Contact Person Email
- valonsoo@salud.aragon.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rocio Garcia Carbonero
- Principal Investigator Email
- rgcarbonero@salud.madrid.org
- Contact Person Name
- Rocio Garcia Carbonero
- Contact Person Email
- rgcarbonero@salud.madrid.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Cristina Santos Vivas
- Principal Investigator Email
- contactfortrialsICOLH@iconcologia.net
- Contact Person Name
- Cristina Santos Vivas
- Contact Person Email
- contactfortrialsICOLH@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Maria Reyes Ferreiro Monteagudo
- Principal Investigator Email
- mariareyes.ferreiro@salud.madrid.org
- Contact Person Name
- Maria Reyes Ferreiro Monteagudo
- Contact Person Email
- mariareyes.ferreiro@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology dept.
- Principal Investigator Name
- Maria Elena Elez Fernandez
- Principal Investigator Email
- meelez@vhio.net
- Contact Person Name
- Maria Elena Elez Fernandez
- Contact Person Email
- meelez@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pilar Garcia Alfonso
- Principal Investigator Email
- pgarciaalfonso@salud.madrid.org
- Contact Person Name
- Pilar Garcia Alfonso
- Contact Person Email
- pgarciaalfonso@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Anna Cristina Virgili Manrique
- Principal Investigator Email
- avirgili@santpau.cat
- Contact Person Name
- Anna Cristina Virgili Manrique
- Contact Person Email
- avirgili@santpau.cat
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Jose Luis Cuadra Urteaga
- Principal Investigator Email
- joseluis.cuadra@iob-onco.com
- Contact Person Name
- Jose Luis Cuadra Urteaga
- Contact Person Email
- joseluis.cuadra@iob-onco.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 7
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Hospital De Santa Maria E.P.E.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Catarina Abreu
- Principal Investigator Email
- catarinaabreupm@hotmail.com
- Contact Person Name
- Catarina Abreu
- Contact Person Email
- catarinaabreupm@hotmail.com
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Unidade Local de Saúde de Coimbra - Oncology Department
- Principal Investigator Name
- Anabela Barros
- Principal Investigator Email
- anabela.barros@ulscoimbra.min-saude.pt
- Contact Person Name
- Anabela Barros
- Contact Person Email
- anabela.barros@ulscoimbra.min-saude.pt
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Digestive Unit
- Principal Investigator Name
- Nuno Couto
- Principal Investigator Email
- nuno.couto@fundacaochampalimaudp.pt
- Contact Person Name
- Nuno Couto
- Contact Person Email
- nuno.couto@fundacaochampalimaudp.pt
- Site Name
- Hospital Da Luz S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Catarina Pulido
- Principal Investigator Email
- catarina.pulido@hospitaldaluz.pt
- Contact Person Name
- Catarina Pulido
- Contact Person Email
- catarina.pulido@hospitaldaluz.pt
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Medical Oncology
- Principal Investigator Name
- João Sobrinho Carvalho
- Principal Investigator Email
- jdsobrinhocarvalho@gmail.com
- Contact Person Name
- João Sobrinho Carvalho
- Contact Person Email
- jdsobrinhocarvalho@gmail.com
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Oncology Department
- Principal Investigator Name
- Hélder Mansinho
- Principal Investigator Email
- helder.mansinho@ulsas.min-saude.pt
- Contact Person Name
- Hélder Mansinho
- Contact Person Email
- helder.mansinho@ulsas.min-saude.pt
Hungary
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 1
- Number Of Sites
- 1
- Number Of Participants
- 29
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Department of chest and abdominal tumors and clinical pharmacology
- Principal Investigator Name
- Németh Zsuzsanna
- Principal Investigator Email
- nemethstudy@gmail.com
- Contact Person Name
- Németh Zsuzsanna
- Contact Person Email
- nemethstudy@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 08-08-2024
- Processing Time Days
- 9
- Number Of Sites
- 4
- Number Of Participants
- 44
Sites
- Site Name
- Haematologisch Onkologische Praxis Eppendorf
- Department Name
- Haematologically
- Principal Investigator Name
- Alexander Stein
- Principal Investigator Email
- stein@hope-hamburg.de
- Contact Person Name
- Alexander Stein
- Contact Person Email
- stein@hope-hamburg.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Asklepios Clinical Altona
- Principal Investigator Name
- Dirk Arnold
- Principal Investigator Email
- d.arnold@asklepios.com
- Contact Person Name
- Dirk Arnold
- Contact Person Email
- d.arnold@asklepios.com
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- IKF Hospital Northwest
- Principal Investigator Name
- Thorsten Oliver Götze
- Principal Investigator Email
- Info.IKF@khnw.DE
- Contact Person Name
- Thorsten Oliver Götze
- Contact Person Email
- Info.IKF@khnw.DE
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medical Clinic and Polyclinic I
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- oncostudy@uniklinikum-dresden.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- oncostudy@uniklinikum-dresden.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 1
- Number Of Sites
- 3
- Number Of Participants
- 36
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology and Gasto-Enterology Department
- Principal Investigator Name
- Marc Van Den Eynde
- Principal Investigator Email
- International-saintluc@uclouvain.be
- Contact Person Name
- Marc Van Den Eynde
- Contact Person Email
- International-saintluc@uclouvain.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Oncology department
- Principal Investigator Name
- Donatienne Taylor
- Principal Investigator Email
- comite.ethique.se@chuuclnamur.uclouvain.be
- Contact Person Name
- Donatienne Taylor
- Contact Person Email
- comite.ethique.se@chuuclnamur.uclouvain.be
- Site Name
- AZ Turnhout
- Department Name
- Gastro-enterology and digestive oncology
- Principal Investigator Name
- Leen Simonne Mortier
- Principal Investigator Email
- leen.mortier@azturnhout.be
- Contact Person Name
- Leen Simonne Mortier
- Contact Person Email
- leen.mortier@azturnhout.be
Poland
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 5
- Number Of Sites
- 5
- Number Of Participants
- 70
Sites
- Site Name
- Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- Oncology department
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- sekretariat@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- sekretariat@onkologia.opole.pl
- Site Name
- Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
- Department Name
- Oncology department
- Principal Investigator Name
- Magdalena Ciążyńska
- Principal Investigator Email
- magda.gozdz@gmail.com
- Contact Person Name
- Magdalena Ciążyńska
- Contact Person Email
- magda.gozdz@gmail.com
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Oncology department
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- sekretariatdn@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- sekretariatdn@co.bydgoszcz.pl
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Oncology department
- Principal Investigator Name
- Daria Kwaśniewska
- Principal Investigator Email
- sekretariatckk@cskmswia.gov.pl
- Contact Person Name
- Daria Kwaśniewska
- Contact Person Email
- sekretariatckk@cskmswia.gov.pl
- Site Name
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej i Radioterapii
- Principal Investigator Name
- Lubomir Bodnar
- Principal Investigator Email
- lbodnar@szpital.siedlce.pl
- Contact Person Name
- Lubomir Bodnar
- Contact Person Email
- lbodnar@szpital.siedlce.pl
Sponsor
Primary sponsor
- Full Name
- Exelixis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- SUSAR reporting; other trial management responsibilities (multiple duty codes listed)
- Name
- Icon Development Solutions LLC
- Name
- Bioclinica Inc.
- Responsibilities
- ePRO
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical imaging
- Name
- 4g Clinical LLC
- Name
- WCG Clinical Inc.
- Responsibilities
- Central ECG
- Name
- Icon Laboratory Services Inc.
- Name
- Medidata Solutions Inc.
- Name
- Imperial Clinical Research Services International Ltd.
- Responsibilities
- Printing of study materials
- Name
- Scout Clinical
- Responsibilities
- Travel reimbursement coordination (France, Hungary, Poland)
Third parties
- {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"PK Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"RAS Mutational Profile","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ePRO","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"SUSAR reporting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Printing of study materials","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Allucent (US) LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"MSI Mutational Profile, Laboratory Kits/Manuals","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"France, Hungary, and Poland travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Drug Depot","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Spain patient travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Ancillary equipment for sites","organisation_type":"Non-Pharmaceutical company"}
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 USE
- Route
- Oral
- Authorisation Status
- Investigational / not marketing authorised (prodAuthStatus=1)
- Maximum Dose
- 120.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation (prodAuthStatus=2)
- Investigational Product Name
- Stivarga 40 mg film-coated tablets
- Active Substance
- REGORAFENIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Marketing authorisation (prodAuthStatus=2)
- Maximum Dose
- 160.00 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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