Clinical trial • Phase III • Oncology

Niraparib tosilate monohydrate for Glioblastoma (MGMT promoter unmethylated)

Phase III trial of Niraparib tosilate monohydrate for Glioblastoma (MGMT promoter unmethylated).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Glioblastoma (MGMT promoter unmethylated)
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
14-08-2024
First CTIS Authorization Date
02-12-2024

Trial design

Randomised, open-label, temozolomide (temozolomide) — comparator; route: oral; dose/schedule: not specified in provided data.-controlled Phase III trial in Denmark, Ireland, Norway and others.

Randomised
Yes
Open Label
Yes
Comparator
Temozolomide (TEMOZOLOMIDE) — comparator; route: oral; dose/schedule: Not specified in provided data.
Target Sample Size
235

Eligibility

Recruits 235 Vulnerable population selected. Requirement: "The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol." Participants must be ≥18 years and provide their own signed informed consent. No assent/parental consent procedures for minors are included..

Pregnancy Exclusion
Female participants: Not pregnant, planning to get pregnant, or breastfeeding and one of the following conditions apply: is of nonchildbearing potential or is of childbearing potential AND using a contraceptive method that is highly effective (with a failure rate of <1% per year) from screening through at least 180 days after the last dose of study intervention. Breastfeeding is contraindicated during the study and for one month after the last dose of study intervention.
Vulnerable Population
Vulnerable population selected. Requirement: "The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol." Participants must be ≥18 years and provide their own signed informed consent. No assent/parental consent procedures for minors are included.

Inclusion criteria

  • {"criterion_text":"- Histologic documentation of a newly-diagnosed intracranial GBM, per 2021 WHO classification guidelines through local pathology review.\n- Karnofsky performance status of ≥70.\n- Adequate organ function\n- Normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg).\n- Stable or decreased dose of dexamethasone, requiring no more than 5 mg daily equivalent dose, within 7 days before randomization. Participants on other corticosteroids must not exceed an equivalent dose. .\n- Ability to swallow oral medications whole.\n- Age ≥18 years at the time of signing informed consent.\n- Sufficient tissue available for retrospective central pathology review and genomic analysis. If insufficient tissue is available, approval may be granted on a case-by-case basis after a review.\n- Unmethylated MGMT promoter region determined locally by a validated PSQ or qMS-PCR assay compliant to local regulations. Numerical cut-off for an MGMT unmethylated tumor as defined in the protocol.\n- Suitability for SOC RT to 60 Gy in 30 fractions using ESTRO-EANO 'single phase' targeting approach, per investigator's judgment.\n- No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.\n- Female participants: Not pregnant, planning to get pregnant, or breastfeeding and one of the following conditions apply: is of nonchildbearing potential or is of childbearing potential AND using a contraceptive method that is highly effective (with a failure rate of <1% per year) from screening through at least 180 days after the last dose of study intervention. Breastfeeding is contraindicated during the study and for one month after the last dose of study intervention.\n- Male participants: Must agree to the following during the study intervention period and for at least 6 months after the last dose of study intervention: refrain from donation sperm PLUS be abstinent from heterosexual activity or agree to use a male condom and be advised of the benefit for a female partner to use a contraceptive method that is highly effective (with a failure rate of <1% per year).\n- The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Presence of metastatic or predominant leptomeningeal disease.\n- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study requirements and/or follow-up procedures.\n- Inability to undergo MRI brain with IV contrast.\n- Biopsy and/or resection (whichever is later) occurring >6 weeks prior to planned RT start date.\n- Surgical wound complication recovery at the time of enrollment.\n- Known hypersensitivity to the components of niraparib, TMZ, or their formulation excipients.\n- Known hypersensitivity to dacarbazine (DTIC).\n- Prior therapy with PARP inhibitors for systemic cancer.\n- Received a live vaccine within 30 days before the planned start of study intervention. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live.\n- Received a transfusion (platelets or red blood cells) or colony-stimulating factors (e.g., granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks of the planned start of study intervention.\n- Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product.\n- Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.\n- Treatment with tumor treating fields (e.g., Optune) for GBM.\n- Presence of known isocitrate dehydrogenase (IDH) mutation.\n- Presence of known H3 mutation.\n- Previous diagnosis of WHO Grade 2 or 3 glioma.\n- Participant is at an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to start of study treatment with the exception of tumor resection)\n- Any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.\n- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. NOTE: Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones), hepatobiliary involvement of malignancy, or chronic stable HBV infection (in a participant for whom HDV infection has been excluded) or chronic HCV infection is acceptable if the participant otherwise meets entry criteria.\n- Known human immunodeficiency virus (HIV) unless participants meet all of the following criteria: - Cluster of differentiation 4 ≥350/µL and viral load <400 copies/mL. - No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment. - No history of HIV-associated malignancy for the past 5 years. - Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV [NIH, 2021] started >4 weeks prior to study enrollment.\n- MDS/AML or with features suggestive of MDS/AML.\n- History of another malignancy within 2 years prior to registration. Participants with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Participants with a history of other malignancies are eligible if they have been treated with curative intent or continuously disease free for at least 2 years after definitive primary treatment.\n- Prior history of posterior reversible encephalopathy syndrome (PRES)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival, defined as the time from the date of randomization to the date of death due to any cause","definition_or_measurement_approach":"Defined as the time from the date of randomization to the date of death due to any cause (overall survival)."}

Secondary endpoints

  • {"endpoint_text":"- Overall response rate, defined as confirmed complete response or confirmed partial response, as per RANO 2.0 by BICR assessment","definition_or_measurement_approach":"Confirmed complete response or confirmed partial response according to RANO 2.0 assessed by Blinded Independent Central Review (BICR)."}
  • {"endpoint_text":"- Compare symptoms, function, and HRQoL at baseline to the specified timepoints in the schedule of assessments","definition_or_measurement_approach":"Comparison of symptoms, function and health-related quality of life (HRQoL) measures at baseline vs specified timepoints per schedule of assessments (using specified PRO instruments e.g., EORTC QLQ-C30/BN20, EQ-5D)."}
  • {"endpoint_text":"- Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test, Controlled Oral Word Association, and Trail Making Test Parts A and B","definition_or_measurement_approach":"Neurocognitive assessments using HVLT-R, Controlled Oral Word Association (COWA), and Trail Making Test Parts A and B; changes from baseline will be evaluated."}
  • {"endpoint_text":"- •\tIncidence of AEs, SAEs, and AESIs •\tIncidence of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements •\tFrequency and severity of symptomatic AEs based on PRO-CTCAE","definition_or_measurement_approach":"Safety endpoints include incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs); treatment discontinuations, dose interruptions/reductions due to AEs/SAEs/AESIs; changes in KPS, laboratory results, vital signs; and symptomatic AE frequency/severity per PRO-CTCAE."}
  • {"endpoint_text":"- Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first","definition_or_measurement_approach":"Defined as time from randomization to first disease progression per RANO 2.0 by BICR or death from any cause, whichever occurs first."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
235
Recruitment Window Months
40
Consent Approach
Participants must be capable of providing signed informed consent: "The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol." Age requirement is ≥18 years. Separate subject information and informed consent documents exist (e.g., 'L1_SIS and ICF Main', 'L1_SIS and ICF pregnant partner', 'L1_SIS and ICF Main_separate consent form', and country/language-specific ICFs). Available language/local versions include English, Danish (DNK), Dutch (NL), French (FR), Spanish (ES), German (DE), Italian (IT), Norwegian (NO) as shown in the document list. A separate consent form is provided for pregnant partners as indicated in documents.

Methods

  • Social media posts / Clinical Trial Posts (documents titled e.g., 'Gliofocus Social Media and Clinical Trial Posts', 'Social Media and Clinical Trial Posts') — channel: social media; target audience: patients/general public; country-specific versions available (Netherlands, Norway, Spain, Germany, Ireland, France, Denmark, Italy).
  • Online advertisements / Banner ads (documents titled 'Online Advertisements_Banners', 'Online Advertisements_Banners_san') — channel: web banners/online ads; target: patients/caregivers; country-specific versions available (IRL, DEU, NLD, FRA, DK, NOR, ESP, ITA).
  • Patient-facing brochure / Patient Brochure (documents titled 'Patient Brochure', 'Patient Brochure_San') — channel: printed/PDF brochure; target: potential participants/patients; country-specific language versions available.
  • Physician Referral Letter (documents titled 'Physician Referral Letter') — channel: direct outreach to healthcare professionals for referrals; country-specific versions available.

Geography

Total Number Of Sites
53
Total Number Of Participants
215

Denmark

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
4
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Charlotte Haslund
Contact Person Email
cah@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Slávka Lukacova
Contact Person Email
slavka.lukacova@auh.rm.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Benedikte Hasselbalch
Site Name
Odense University Hospital
Department Name
Oncology Department R
Contact Person Name
Rikke Dahlrot
Contact Person Email
rikke.dahlrot@rsyd.dk

Ireland

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
44
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Beaumont Hospital
Department Name
Oncology
Contact Person Name
Jack Gleeson
Contact Person Email
jack.gleeson@hse.ie
Site Name
Cork University Hospital
Department Name
Oncology
Contact Person Name
Patrick Morris
Contact Person Email
patrickmorris@beaumont.ie

Norway

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Contact Person Name
Petter Brandal
Contact Person Email
petter.brandal@ous-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Department of clinical and molecular medicine
Contact Person Name
Tora Solheim

Italy

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
06-12-2024
Processing Time Days
100
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Radioterapia Oncologica
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Neuro-oncology
Contact Person Name
Antonio Silvani
Site Name
Azienda Sanitaria Locale Napoli 1 Centro
Department Name
UOC Oncologia
Contact Person Name
Bruno Daniele
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Neuro-oncology
Contact Person Name
Roberta Rudà
Contact Person Email
roberta.ruda@unito.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Neuro-oncology
Contact Person Name
Matteo Simonelli
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia
Contact Person Name
Giuseppe Lombardi
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Radioterapia Oncologica
Contact Person Name
Giuseppe Minniti
Contact Person Email
giuseppe.minniti@uniroma1.it
Site Name
Instituto Di Ricovero E Cura A Carattere Scientifico (Ospedale Bellaria)
Department Name
UOC Oncologia
Contact Person Name
Enrico Franceschi
Contact Person Email
e.franceschi@isnb.it

France

Earliest CTIS Part Ii Submission Date
21-10-2024
Latest Decision Or Authorization Date
05-12-2024
Processing Time Days
45
Number Of Sites
10
Number Of Participants
46

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Carole GOURMELON
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Aurélien MAUREILLE
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Amélie DARLIX
Contact Person Email
amelie.darlix@icm.unicancer.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
CEPCM
Contact Person Name
Emeline TABOURET
Contact Person Email
emeline.tabouret@ap-hm.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology
Contact Person Name
François GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Contact Person Name
Elodie VAULEON
Contact Person Email
e.vauleon@rennes.unicancer.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Medical Oncology
Contact Person Name
Mathieu BOONE
Contact Person Email
boone.mathieu@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurology
Contact Person Name
Véronique BOURG
Contact Person Email
bourg.v@chu-nice.fr
Site Name
Hospices Civils De Lyon
Department Name
Neuro-Oncology
Contact Person Name
François DUCRAY
Contact Person Email
francois.ducray@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurology
Contact Person Name
Medhi TOUAT
Contact Person Email
medhi.touat@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
03-12-2024
Processing Time Days
14
Number Of Sites
10
Number Of Participants
46

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Neurologie-NeruOnkologie
Contact Person Name
Peter Hau
Contact Person Email
peter.hau@ukr.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Neurooncology, Center of Neurology
Contact Person Name
Antje Wick
Site Name
Heidelberg University
Department Name
Neurology Clinic
Contact Person Name
Lukas Bunse
Contact Person Email
lukas.bunse@umm.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Neurology and Interdisciplinary Neuro-Oncology
Contact Person Name
Ghazaleh Tabatabai
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Fachbereich Hämatologie, Onkologie und Palliativmedizinie
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Department of Neurooncology
Contact Person Name
Ulrich Herrlinger
Contact Person Email
ulrich.herrlinger@ukbonn.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Neurochirurgie
Contact Person Name
Sven-Axel May
Contact Person Email
s-a.may@skc.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik für Strahlentherapie und Radioonkologie
Contact Person Name
Clemens Seidel
Site Name
Goethe University Frankfurt
Department Name
Center for Neurology and Neurosurgery
Contact Person Name
Michael Burger
Contact Person Email
burger@med.uni-frankfurt.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Neurosurgery
Contact Person Name
Martin Misch
Contact Person Email
martin.misch@charite.de

Netherlands

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
09-12-2024
Processing Time Days
11
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Neuro Oncology
Contact Person Name
Dieta Brandsma
Contact Person Email
d.brandsma@nki.nl
Site Name
Vrije Universiteit
Department Name
Medical Oncology
Contact Person Name
Myra van Linde
Contact Person Email
vanlinde@vumc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medical Oncology
Contact Person Name
Josefine Schopman
Contact Person Email
j.e.schopman@lumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Head and Neck Neuro Oncologist
Contact Person Name
Ann Hoeben
Contact Person Email
ann.hoeben@mumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Contact Person Name
Filip de Vos
Contact Person Email
f.devos@umcutrecht.nl

Spain

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
11
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Miriam Alonso Garcia
Contact Person Email
miriamag3@hotmail.com
Site Name
Clinica Universidad De Navarra
Department Name
neurology
Contact Person Name
Jaime Gallego Perez de Larraya
Contact Person Email
jgallego@unav.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Angela Santiago Gomez
Contact Person Email
asantiago@hmhospitales.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Sonia Del Barco Berron
Contact Person Email
sdelbarco@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Estela Pineda Losada
Contact Person Email
EPINEDA@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Juan Manuel Sepulveda Sanchez
Contact Person Email
jmsepulveda76@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
María Vieito Villar
Contact Person Email
mvieito@vhio.net
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Maria Martinez Garcia
Contact Person Email
mariamartinezgarcia@psmar.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology
Contact Person Name
Luis Miguel Navarro Martin
Contact Person Email
oncologiamnavarro@yahoo.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Raquel Serrano Blanch
Contact Person Email
rsblanch@hotmail.com
Site Name
Institut Catala D'oncologia (L'Hospitalet)
Department Name
Oncology
Contact Person Name
Noelia Vilariño Quintela
Contact Person Email
nvilarino@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Maria Angeles Vaz Salgado
Contact Person Email
mavaz4@gmail.com

Sponsor

Primary sponsor

Full Name
Neurotrials LLC
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
Multiple operational roles including electronic data services and vendor management (sponsorDuties codes include 1,2,4,5,6,8,10-13,15; see third_parties for details and provided value describing EPROM/ECOPA-related responsibilities).
Name
Iqvia Rds Inc.
Responsibilities
IRT/global helpdesk (sponsorDuties code 3).
Name
Medidata Solutions Inc.
Responsibilities
Sponsor duties code 7 (as listed).

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"id\":952784,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"[{\"id\":952787,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"[{\"id\":952788,\"code\":\"15\",\"value\":\"Central image vendor and BICR review of images\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"[{\"id\":952783,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"id\":952773,\"code\":\"1\"},{\"id\":952774,\"code\":\"10\"},{\"id\":952775,\"code\":\"11\"},{\"id\":952776,\"code\":\"12\"},{\"id\":952777,\"code\":\"13\"},{\"id\":952778,\"code\":\"15\",\"value\":\"Other Electronic Patient Reported Outcomes, Electronic Clinical Outcome Assessments, Clinical Outcomes Training, and Scale Delivery, Vendor management\"},{\"id\":952779,\"code\":\"2\"},{\"id\":952780,\"code\":\"5\"},{\"id\":952781,\"code\":\"6\"},{\"id\":952782,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"[{\"id\":952785,\"code\":\"15\",\"value\":\"Lab kit creation and shipment for MGMT, biomarker and PK samples. Sample storage for MGMT and PK samples, and Biomarker sample processing and storing\"},{\"id\":952786,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Niraparib (Zejula / sponsor product GSK3985771)
Active Substance
Niraparib tosilate monohydrate
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation in EU for product Zejula (marketingAuthNumber: EU/1/17/1235/004) and sponsor investigational product entry present
Orphan Designation
Yes
Maximum Dose
200 mg (maxDailyDoseAmount as listed in product entry)
Investigational Product Name
Temozolomide (TEMOZOLOMIDE) - Comparator
Active Substance
Temozolomide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Product entry present (EU/substance listing), marketing authorisation number not provided in this record
Maximum Dose
200 mg/m2 (maxDailyDoseAmount as listed in product entry)

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