Clinical Trials Register

Summary
EudraCT Number:	2021-000565-32
Sponsor's Protocol Code Number:	PRIDE
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2023-01-27
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2021-000565-32

A.3

Full title of the trial

PRIDE: A phase II a, open-label, multicenter study of radiochemotherapy with isotoxic dose escalation and protective VEGF inhibition using bevacizumab in the treatment of patients with first diagnosis of IDH wild-type, MGMT unmethylated glioblastoma

PRIDE: Eine multizentrische Phase II a-Studie zur Radiochemotherapie mit isotoxischer Dosiseskalation und protektiver VEGF-Inhibition mit Bevacizumab bei der Behandlung von Patienten mit der Erstdiagnose eines IDH-Wildtyp, MGMT unmethylierten Glioblastoms

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

PRIDE: Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma

PRIDE: Protektive VEGF-Inhibition zur isotoxischen Dosiseskalation beim Glioblastom

A.3.2

Name or abbreviated title of the trial where available

PRIDE

A.4.1

Sponsor's protocol code number

PRIDE

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Klinikum der Universität München
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Deutsche Krebshilfe
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Münchner Studienzentrum der TU München Fakultät für Medizin
B.5.2	Functional name of contact point	Dr. med. Christiane Blankenstein
B.5.3	Address:
B.5.3.1	Street Address	Ismaninger Str. 22
B.5.3.2	Town/ city	München
B.5.3.3	Post code	81675
B.5.3.4	Country	Germany
B.5.4	Telephone number	00498941406321
B.5.5	Fax number	00498941406322
B.5.6	E-mail	muenchner.studienzentrum@mri.tum.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Bevacizumab
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bevacizumab
D.3.9.1	CAS number	216974-75-3
D.3.9.4	EV Substance Code	SUB16402MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.5 mg/kg
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Bevacizumab (Aybintio®) is a monoclonal antibody from the immunoglobulin group (IgG1) that targets the vascular endothelial growth factor (VEGF).

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Glioblastoma

Glioblastom

E.1.1.1

Medical condition in easily understood language

Glioblastoma (malignant brain tumor)

Glioblastom (bösartiger Hirntumo).

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10018336
E.1.2	Term	Glioblastoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Overall survival

Gesamtüberleben

E.2.2

Secondary objectives of the trial

Safety and tolerability of isotoxic dose escalation and bevacizumab
Progression-free survival after 6 months (PFS-6)
Progression-free survival (PFS)
Quality of life as determined by EORTC QLQ-C30 and the EORTC brain module QLQ-BN 20.
Cognitive function as determined by MMSE and MOCA
Exploratory objective: validation of 4-miRNA signature-based risk subgroups in FFPE material and plasma samples

Sicherheit und Toleranz der Dosiseskalation mit Bevacizumab
6-Monats-Rate des Progressionsfreien Überlebens (PFS-6)
Progressionsfreies Überleben (PFS)
Lebensqualität erhoben mit den EORTC-Bögen QLQ-C30 und EORTC brain module QLQ-BN 20
Neurokognition ermittelt mittels MMSE und MOCA
Explorativer Endpunkt: Validierung prognostischer 4-miRNA-Subgruppen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Diagnosis of glioblastoma, IDH-wildtype and MGMT unmethylated status must be proven histologically. MRI images must not be older than 2 weeks before initiating RT
2. ≥ 18 and ≤ 70 years of age, smoking or non-smoking, of any ethnic origin
3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0–2
4.Patient must have provided signed informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and consent obtained prior to any study-specific procedure). This includes the willingness to give written informed consent, written consent for data protection (according to the German General Data Protection Regulation (Datenschutz-Grundverordnung, DSGVO) in addition to willingness to participate and comply with the study.
5.Craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of inclusion
6.Adequate hematological function: white blood cell (WBC) count  3x109/L, absolute neutrophil count (ANC) >1,5x109/L, platelet count 100x109/L, hemoglobin ≥ 8 g/dl (may be obtained by the use of erythropoietin-stimulating agents or transfusion for anemia)
7.Adequate liver function: Total bilirubin < 1.5 x upper limit of normal (ULN) AND
aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 x ULN
8.Adequate renal function: Serum creatinine ≤ 1.5 x ULN AND patients with urine dipstick for proteinuria < 2+.
9.International normalized ratio (INR) (in absence of anticoagulation treatment) ≤ 1.5 within 7 days prior to enrolment. Anticoagulation is allowed if target INR is < 3 and if the patient is on a stable dose of anticoagulant (coumarin type, low molecular weight heparin (LMWH) or bivalirudin or argatroban) for >2 weeks at time of enrolment. Therefore, during the study, the preferred choice for anticoagulation treatment with therapeutic intent should be low molecular weight heparin as per ASCO guidelines.
10.Women of childbearing potential (i.e., a woman, who is biologically capable of becoming pregnant) must have a negative serum (β-HCG) pregnancy test within 7 days prior to the first dose of study medication and radiotherapy; adequate contraception should be applied.

1.Neu diagnostiziertes Glioblastom WHO Grad 4 IDHwt, MGMT nicht methyliert
2.Gültige Einverständniserklärung
3.Alter von 18 bis 70 Jahre, Raucher oder Nichtraucher, jede ethnische Zugehörigkeit
4.ECOG 0-2
5.Neutrophile Granulozyten > 1500/μl; Thrombozyten > 100.000/μl; Hämoglobin > 8 g/dl; Bilirubin, AST oder ALT < 2,5-faches oberes Limit des Normwerts, außer falls durch Antikonvulsiva verursacht; Alkalische Phosphatase < 2,5-faches oberes Limit des Normwerts
6.Adäquate Kontrazeption
7.Serumkreatinin ≤ 1,5-faches oberes Limit des Normwerts UND Urin-Stix Proteinurie < 2+. Patienten, die ≥ 2+ Proteinurie im Urin-STIX zur Baseline sollten eine Urinprotein/Serumkreatinin-Ratio ≤ 1 aufweisen

E.4

Principal exclusion criteria

1. Positive test results for HbsAG, anti-HCV, anti-HIV-1/-2
2. Any other condition or treatment that, in the opinion of the Investigator, might interfere with the study or current drug
3. Controlled substance abuse according to the German Narcotic Drugs Act (Betäubungsmittelgesetz, BtMG)
4. Past medical history of diseases with poor prognosis according to the judgement of the investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
5. Foreseeable non-compliance with the protocol requirements, instructions and study-related restrictions, e.g. uncooperative attitude, inability to return for follow-up visits, and low probability of completing the study
6. Pregnancy or breast feeding
7. Patient is the investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.
8. Evidence of recent hemorrhage on postoperative MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor are permitted entry into the study
9. Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field
10. Patients simultaneously enrolled in another clinical trial or patients who participated in another clinical trial during the 28 days (or five-half lives of the respective investigational product, whichever is longer) before enrolment
11.Patients who previously participated in this trial
12.Evidence for any active infection requiring hospitalization or i.v. antibiotics within 2 weeks prior to inclusion
13.Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
14.Patients who possibly are dependent on the sponsor or investigator.
15.Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)
16.History of chronic gastrointestinal disease with diarrhea; history of abdominal or pelvic radiotherapy
17.Any other significant medical illness or medically significant laboratory finding that would, in the investigator’s judgement, make the patient inappropriate for this study, or would increase the risk associated with the patients’ participation in the study
18.Inability to undergo MRI
19.Contraindication and/or hypersensitivity to bevacizumab or its excipients. For details check the Summary of Product Characteristics of Aybintio®
20.Prior treatment with bevacizumab for any indication
21.Parallel administration of any drug suspected to interfere with bevacizumab at the time of inclusion
22.Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, IV), unstable angina pectoris or myocardial infarction within 6 months prior to enrolment
23. Inadequately controlled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or >100 mmHg diastolic on medication) or any prior history of hypertensive crisis or hypertensive encephalopathy
24. History of stroke or transient ischemic attack within 6 months prior to enrolment
25. Significant vascular disease (e.g., aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to enrolment
26.Evidence or history of recurrent thromboembolism (> 1 episode of deep venous thrombosis / peripheral embolism) during the past 2 years
27.Evidence of bleeding diathesis of coagulopathy (in the absence of therapeutic anticoagulation)
28.Chronic daily intake of aspirin > 325 mg/day or clopidogrel > 75 mg/day
29.History of intracranial abscess within 6 months prior to inclusion
30.History of abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrolment
31.History of ≥ grade 2 hemoptysis according to NCI-CTC criteria within 1 month prior to inclusion
32.Serious non-healing wound, ulcer or bone fracture
33.Placement of a central vascular access device (CVAD) within 2 days prior to bevacizumab administration

1.Positive Testergebnisse für HbsAG, Anti-HCV, Anti-HIV-1/-2
2.Jede andere Erkrankung oder Behandlung, die nach Ansicht des Prüfers die Studie oder das aktuelle Medikament beeinträchtigen könnte
3.Missbrauch kontrollierter Substanzen nach dem deutschen Betäubungsmittelgesetz (BtMG)
4.Erkrankungen in der Vorgeschichte, die nach dem Urteil des Prüfarztes eine schlechte Prognose haben, z.B. schwere koronare Herzkrankheit, schwere Diabetes, Immunschwäche, Restdefizite nach Schlaganfall, schwere geistige Behinderung
5.Vorhersehbare Nichteinhaltung der Anforderungen des Prüfplans, der Anweisungen und der studienbezogenen Einschränkungen, z. B. unkooperatives Verhalten, Unfähigkeit, zu Nachuntersuchungen zu erscheinen, und geringe Wahrscheinlichkeit, die Studie abzuschließen
6.Schwangerschaft oder Stillen
7.Der Patient ist der Prüfer, die Forschungsassistentin, der Apotheker, der Studienkoordinator, sonstiges Personal oder ein Verwandter, der direkt an der Durchführung der Studie beteiligt ist.
8.Nachweis einer kürzlich aufgetretenen Blutung im postoperativen MRT des Gehirns. Patienten mit klinisch asymptomatischem Vorhandensein von Hämosiderin, sich auflösenden hämorrhagischen Veränderungen im Zusammenhang mit der Operation und dem Vorhandensein einer punktförmigen Blutung im Tumor dürfen jedoch an der Studie teilnehmen.
9.Jegliche vorherige Strahlentherapie des Gehirns oder vorherige Strahlentherapie, die zu einer potenziellen Überlappung im Strahlenfeld führt
10.Patienten, die gleichzeitig an einer anderen klinischen Studie teilnehmen, oder Patienten, die innerhalb von 28 Tagen (oder fünf Halbwertszeiten des jeweiligen Prüfpräparats, je nachdem, welcher Zeitraum länger ist) vor der Aufnahme in die Studie an einer anderen klinischen Studie teilgenommen haben
11.Patienten, die bereits an dieser Studie teilgenommen haben
12.Anzeichen für eine aktive Infektion, die einen Krankenhausaufenthalt oder eine intravenöse Antibiotikagabe innerhalb von 2 Wochen vor der Aufnahme in die Studie erfordert
13.Minderjährige Patienten oder Patienten, die nicht in der Lage sind, das Ziel, die Bedeutung und die Folgen der Studie zu verstehen und eine rechtmäßige Einwilligung nach Aufklärung zu geben (gemäß § 40 Abs. 4 und § 41 Abs. 2 und Abs. 3 AMG).
14.Patienten, die möglicherweise vom Sponsor oder Prüfer abhängig sind.
15.Patienten mit geschwächtem Immunsystem, einschließlich bekannter Seropositivität für das humane Immundefizienz-Virus (HIV)
16.Chronische gastrointestinale Erkrankungen mit Durchfall in der Vorgeschichte; Strahlentherapie im Bauch- oder Beckenbereich in der Vorgeschichte
17.Jede andere schwerwiegende medizinische Erkrankung oder jeder medizinisch bedeutsame Laborbefund, der den Patienten nach dem Urteil des Prüfarztes für diese Studie ungeeignet macht oder das mit der Teilnahme des Patienten an der Studie verbundene Risiko erhöhen würde
18.Unfähigkeit zur Durchführung einer MRT

19. Kontraindikationen und/oder Hypersensibilitäten gegenüber Bevacizumab und seinen Inhaltsstoffen; Näheres ist in der Fachinformation von Aybintio® beschrieben
20.Vorherige Behandlung mit Bevacizumab aus irgendeiner Indikation
21.Parallele Verabreichung von Arzneimitteln, die im Verdacht stehen, Bevacizumab zu beeinträchtigen, zum Zeitpunkt der Aufnahme in die Studie
22.Signifikante kardiovaskuläre Erkrankung, definiert als kongestive Herzinsuffizienz (NYHA-Klasse II, III, IV), instabile Angina pectoris oder Myokardinfarkt innerhalb von 6 Monaten vor der Aufnahme in die Studie
23.Unzureichend kontrollierter Bluthochdruck (definiert als ein Blutdruck von > 150 mmHg systolisch und/oder >100 mmHg diastolisch unter medikamentöser Behandlung) oder eine hypertensive Krise oder hypertensive Enzephalopathie in der Vorgeschichte
24.Schlaganfall oder transitorische ischämische Attacke in der Vorgeschichte innerhalb von 6 Monaten vor der Aufnahme in die Studie
25.Signifikante Gefäßerkrankung (z. B. Aortenaneurysma, Aortendissektion oder kürzlich aufgetretene periphere arterielle Thrombose) innerhalb von 6 Monaten vor der Aufnahme in die Studie
26.Anzeichen oder Vorgeschichte von rezidivierenden Thromboembolien (> 1 tiefe Venenthrombose/periphere Embolie) in den letzten 2 Jahren
27.Nachweis einer Blutungsdiathese oder Koagulopathie (bei fehlender therapeutischer Antikoagulation)
28.Chronische tägliche Einnahme von Aspirin > 325 mg/Tag oder Clopidogrel > 75 mg/Tag
29.Vorgeschichte eines intrakraniellen Abszesses innerhalb von 6 Monaten vor der Aufnahme
30.Anamnese einer abdominalen oder tracheoösophagealen Fistel, einer gastrointestinalen Perforation oder eines intraabdominalen Abszesses innerhalb der letzten 6 Monate vor Aufnahme in die Studie
31.Anamnese einer Hämoptyse ≥ Grad 2 nach NCI-CTC-Kriterien innerhalb von 1 Monat vor Studieneinschluss
32.Schwere nicht heilende Wunden, Geschwüre oder Knochenbrüche
33.Anlegen eines zentralen Gefäßzugangs (CVAD) innerhalb von 2 Tagen vor der Verabreichung von Bevacizumab

E.5 End points

E.5.1

Primary end point(s)

Overall survival after 2 years

Gesamtüberleben nach 2 Jahren

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years after study inclusion

2 Jahre nach Studieneinschluss

E.5.2

Secondary end point(s)

•Safety and tolerability of isotoxic dose escalation and bevacizumab
•Progression-free survival after 6 months (PFS-6)
•Progression-free survival (PFS)
•Quality of life as determined by EORTC QLQ-C30 and the EORTC brain module QLQ-BN 20.
•Cognitive function as determined by MMSE and MOCA
• Exploratory objective: validation of 4-miRNA

•Sicherheit und Toleranz der Dosiseskalation mit Bevacizumab
•6-Monats-Rate des Progressionsfreien Überlebens (PFS-6)
•Progressionsfreies Überleben (PFS)
•Lebensqualität erhoben mit den EORTC-Bögen QLQ-C30 und EORTC brain module QLQ-BN 20
•Neurokognition ermittelt mittels MMSE und MOCA
•Explorativer Endpunkt: Validierung prognostischer 4-miRNA-Subgruppen

E.5.2.1

Timepoint(s) of evaluation of this end point

After 2 years

Nach 2 Jahren

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

136

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

146

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects will continue their standard routine cancer treatment

Patienten werden ihre Standard-Routine-Behandlung fortführen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-04-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-04-27

P. End of Trial
P.	End of Trial Status	Ongoing

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