Clinical Trials Register

Summary
EudraCT Number:	2017-004157-16
Sponsor's Protocol Code Number:	CABinMET
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-004157-16

A.3

Full title of the trial

Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation

Studio di fase II a singolo braccio con cabozantinib in pazienti con carcinoma polmonare non a piccole cellule con deregolazione di MET

A.3.1

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

Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation

Studio di fase II a singolo braccio con cabozantinib in pazienti con carcinoma polmonare non a piccole cellule con deregolazione di MET

A.3.2

Name or abbreviated title of the trial where available

CABinMET

A.4.1

Sponsor's protocol code number

CABinMET

A.5.4

Other Identifiers

Name:

CABinMET

Number:

CABinMET

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	FONDAZIONE RICERCA TRASLAZIONALE (FORT)
B.1.3.4	Country	Italy
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	IPSEN S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Via San Leonardo, snc- trav. Migliaro
B.5.3.2	Town/ city	Salerno
B.5.3.3	Post code	84131
B.5.3.4	Country	Italy
B.5.4	Telephone number	089-301545
B.5.5	Fax number	089-7724155
B.5.6	E-mail	cabinmet@cr-technology.com

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	Yes
D.2.1.1.1	Trade name	CABOMETYX - 60 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	IPSEN PHARMA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	CABOZANTINIB
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CABOZANTINIB
D.3.9.1	CAS number	1140909-45-3
D.3.9.2	Current sponsor code	CABOZANTINIB
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	SINTESI CHIMICA
D.IMP: 2
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	Yes
D.2.1.1.1	Trade name	CABOMETYX - 40 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	IPSEN PHARMA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	CABOZANTINIB
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cabozantinib
D.3.9.1	CAS number	1140909-45-3
D.3.9.2	Current sponsor code	Cabozantinib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	sintesi chimica
D.IMP: 3
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	Yes
D.2.1.1.1	Trade name	CABOMETYX - 20 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	IPSEN PHARMA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Cabozantinib
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cabozantinib
D.3.9.1	CAS number	1140909-45-3
D.3.9.2	Current sponsor code	Cabozantinib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	SINTESI CHIMICA

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

Stage III B or stage IV non-small cell lung cancer (not a candidate for local therapies with curative intent)

Carcinoma polmonare non a piccole cellule di stadio III B (non candidabile a terapie locali con intento curativo) o di stadio IV

E.1.1.1

Medical condition in easily understood language

Non-Small Cell Lung Cancer

Tumore al polmone non a piccole cellule

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
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

To evaluate the efficacy in term of response rate (RR) of Cabozantinib in NSCLC patients with MET amplification or MET exon 14 skipping mutation pretreated or not with MET inhibitors.

Valutare l'efficacia in termini di Response Rate (RR) del Cabozantinib in una coorte di pazienti NSCLC con amplificazione di MET o con mutazione attivante di MET a carico dell'esone 14, pre-trattati o no con inibitori di MET

E.2.2

Secondary objectives of the trial

Not applicable

Non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Citological or histological diagnosis of NSCLC non-small-cell-lung cancer (NSCLC) stage III B (notn suitable for local treatments with curative intent) or stage IV.
2. Tissue samples available for MET analysis (archivial tissue or tissue collected at study entry); patients without archival tumor tissue or refusing new biopsy at study entry, are eligible if MET mutation is detected in cf-DNA
3. Presence of MET mutations (exon 14 skipping mutation ONLY) detected in tissue or cf-DNA at the local lab or in the central lab or MET amplification (MET/CEP7 ratio > 2.2) detected in the central lab ONLY.
4. Measurable disease according to RECIST criteria version 1.1
5. At least 1 prior line of standard therapy (chemotherapy and/ or immunotherapy)
6. Performance status 0-1 (ECOG)
7. Age =18 years
8. Patients potentially fertile using adequate methods of contraception in order to avoid childbearing. Contraceptive methods must be respected by male and female patients and their partners during study treatment period and at least 4 months after completing therapy
9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment: 7.a. ANC = 1500 cells/µL without granulocyte colony-stimulating factor support 8.b. Platelet count = 100,000/µL without transfusion 9.c. Hemoglobin = 9.0 g/dL
Patients may be transfused to meet this criterion
d. AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
- Patients with documented liver metastases: AST and/or ALT = 5 × ULN
Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN.
e. Serum bilirubin = 1.25 × ULN
f. Patients with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled
g. Calculated creatinine clearance (CRCL) = 45 mL/min or, if using cisplatin, calculated CRCL must be = 60 mL/min
10. Patient compliance to the study procedure
11. Written informed consent

1. Diagnosi citologica o istologica di carcinoma polmonare non a piccole cellule (NSCLC) di stadio III B (non candidabile a terapie locali con intento curativo) o di stadio IV
2. Disponibilità di campione di tessuto per le analisi di MET (tessuto di archivio o tessuto fresco raccolto all’ingresso nello studio); i pazienti per i quali non sia disponibile tessuto tumorale di archivio o che rifiutino di sottoporsi alla biopsia all’arruolamento, sono eleggibili se la mutazione di MET è rilevata nel cf-DNA
3. Presenza di mutazioni di MET (solo skipping mutation di MET a carico dell’esone 14) rilevate in tessuto o cf-DNA nel laboratorio locale o nel laboratorio centralizzato o amplificazione di MET (MET/CEP7 ratio> 2.2) rilevata esclusivamente presso il laboratorio centralizzato
4. Malattia misurabile in accordo ai criteri RECIST versione 1.1
5. Almeno 1 linea precedente di terapia standard (chemioterapia e/o immunoterapia)
6. Performance status 0-1 (ECOG)
7. Età =18 anni
8. Pazienti potenzialmente fertili che usano adeguati metodi di contraccezione allo scopo di evitare gravidanze. I metodi contraccettivi devono essere rispettati da pazienti di sesso maschile e femminile e dai loro partner durante il periodo di trattamento sperimentale ed almeno fino a 4 mesi dopo il completamento della terapia
9. Adeguata funzionalità ematologica e d’organo, definita dai seguenti esami di laboratorio ottenuti entro 14 giorni precedenti l’arruolamento:
a. ANC = 1500 cell/ µL in assenza di supporto del fattore stimolante la colonia di granulociti
b. Conta piastrinica = 100,000/µL in assenza di trasfusione
c. Emoglobina = 9.0 g/dL
I pazienti possono essere trasfusi per soddisfare questo criterio
d. AST, ALT, e fosfatasi alcalina = 2.5 × ULN, con le seguenti eccezioni:
-pazienti con metastasi al fegato documentate: AST e/o ALT = 5 × ULN
-pazienti con metastasi al fegato o alle ossa: fosfatasi alcalina = 5 × ULN
e. Bilirubina sierica = 1.25 × ULN
f. Pazienti con Sindrome di Gilbert nota che hanno livelli di bilirubina sierica = 3 × ULN possono essere arruolati
g. Clearance della creatinina calcolata (CRCL) = 45 mL/min o la CRCL calcolata deve essere = 60 mL/min
10. Compliance del paziente alle procedure di studio
11. Consenso informato scritto

E.4

Principal exclusion criteria

1. Tissue sample not available in patients without MET exon 14 skipping mutation detected in cf-DNA
2. No possibility to assess MET status
3. Absence of any measurable disease according to RECIST criteria
4. Co-existence of driver events, including EGFR mutations, KRAS mutations, ALK rearrangements or ROS-1 rearrangements
5. No prior therapy
6. Concomitant chemotherapy or immunotherapy or radiotherapy
7. Symptomatic brain metastasis
8. Uncontrolled significant inter-current or recent illness, including cardio-vascular disorders and gastro-intestinal disorders
9. Major surgery within 2 months before first dose of study treatment
10. Concomitant anti-coagulation with oral anti-coagulants or plated inhibitors
11. History of significant bleeding, trachea-bronchial tree/major blood vessels invading tumors, cavity pulmonary lesions and GI disorders associated with a risk of perforation or fistula formation
12. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basalioid)
13. Pregnancy or breastfeeding

1. Tessuto non disponibile in pazienti nei quali non sia stata rilevata una skipping mutation di MET a carico dell’esone 14 nel cf-DNA
2. Nessuna possibilità di valutare lo status di MET
3. Assenza di malattia misurabile in accordo ai criteri RECIST
4. Concomitanza di eventi “driver”, incluse mutazioni EGFR, mutazioni KRAS, riarrangiamenti di ALK o ROS-1
5. Nessuna terapia precedente
6. Concomitante chemioterapia o immunoterapia o radioterapia
7. Metastasi all’encefalo sintomatiche
8. Malattia significativa incontrollata intercorrente o recente, inclusi disordini cardio-vascolari e gastro-intestinali
9. Chirurgia maggiore entro 2 mesi precedenti alla prima dose del trattamento di studio
10. Terapia concomitante con anti- coagulanti orali o antiaggregante piastrinica
11. Storia di emorragia significativa, tumori invasivi dei principali vasi sanguigni tracheobronchiali, lesioni alla cavità polmonare e disordini gastrointestinali associati a rischio di perforazione o di formazione di fistole
12. Diagnosi di un altro tumore negli ultimi 3 anni, eccetto carcinoma in situ della cervice, mammella e vescica o carcinoma della pelle (squamoso o basalioma)
13. Gravidanza o allattamento

E.5 End points

E.5.1

Primary end point(s)

Response Rate (RR) (complete + partial responses) of Cabozantinib in NSCLC patients with MET amplification or MET exon 14 skipping mutation pre-treated or not with MET inhibitors.

Response Rate (RR) (completa + risposta parziale) di Cabozantinib in pazienti NSCLC con amplificazione di MET o con skipping mutation di MET a carico dell’esone 14 pre-trattati o no con inibitori di MET

E.5.1.1

Timepoint(s) of evaluation of this end point

Disease evaluation will be performed according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. every two months (8 weeks) until disease progression, unacceptable toxicity or patient refusal

La valutazione di malattia sarà effettuata in accordo ai criteri RECIST 1.1 ogni 2 mesi (8 settimane) fino a progressione di malattia, tossicità inaccettabile o rifiuto del paziente

E.5.2

Secondary end point(s)

Progression free survival (PFS)
- Overall survival (OS)
- Disease Control Rate (DCR: malattia stabile + risposta parziale + risposta completa)
- Biomarkers esploratori su sangue o tessuto (per ogni paziente arruolato nello studio potrà essere facoltativamente donato un campione di tessuto alla progressione di malattia)

- Progression free survival (PFS)
- Overall survival (OS)
- Disease Control Rate (DCR: stable disease + partial response + complete response)
- Exploratory biomarkers on blood and tissue samples (for each patient enrolled in the study optionally a tissue sample could be provided at disease progression)

E.5.2.1

Timepoint(s) of evaluation of this end point

La valutazione di malattia sarà effettuata in accordo ai criteri RECIST 1.1 ogni 2 mesi (8 settimane) fino a progressione di malattia, tossicità inaccettabile o rifiuto del paziente

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

E.6.4

Safety

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

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.8.2.4

Number of treatment arms in the trial

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

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

Enrolment duration: 24 months
Follow-up duration: at least 12 months

Durata dell’arruolamento: 24 mesi
Durata del Follow-up: almeno 12 mesi

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

F.1.3

Elderly (>=65 years)

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients who are going out of the study will be followed in a short-term follow-up (30 days after the end of treatment) and in the long term (every three months after the end of treatment) during which they will be followed for any adverse events, to new anticancer therapies and to monitoring the progression of the disease

I pazienti usciti dallo studio saranno seguiti in un follow-up a breve termine (30 giorni dopo la fine del trattamento) e a lungo termine (ogni tre mesi dopo la fine del trattamento) durante i quali saranno seguiti in merito agli eventuali eventi avversi, alle nuove eventuali terapie anticancro e al monitoraggio della progressione di malattia

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

2018-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-21

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials