Clinical Trials Register

Summary
EudraCT Number:	2015-001298-42
Sponsor's Protocol Code Number:	1321
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:	2021-01-28
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001298-42

A.3

Full title of the trial

A randomised phase II trial of imatinib alternating with
regorafenib compared to imatinib alone for the first line
treatment of advanced gastrointestinal stromal tumour (GIST)

A.3.1

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

A randomised phase II trial of imatinib alternating with
regorafenib compared to imatinib alone for the first line
treatment of advanced gastrointestinal stromal tumour (GIST)

Studio randomizzato di fase II di imatinib alternato a regorafenib confrontato con imatinib per il trattamento di prima linea del tumore stromale gastrointestinale (GIST) avanzato

A.3.2

Name or abbreviated title of the trial where available

ALT GIST

A.4.1

Sponsor's protocol code number

1321

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02365441

A.5.4

Other Identifiers

Name:

1) NHMR CTC; 2)SSG

Number:

1) CTC 0122/AGITG AG1013GST; 2) ALT-GIST/SSG XXIII

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	EORTC AISBL/IVZW
B.1.3.4	Country	Belgium
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	AGITG
B.4.2	Country	Australia
B.4.1	Name of organisation providing support	Bayer
B.4.2	Country	United States
B.4.1	Name of organisation providing support	EORTC
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	EORTC
B.5.2	Functional name of contact point	Head of Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Avenue E. Mounier 83/11
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1200
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 2 774 1035
B.5.5	Fax number	+32 2 774 1030
B.5.6	E-mail	regulatory@eortc.be

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	GLIVEC - 100 MG 96 CAPSULE RIGIDE USO ORALE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
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	STIVARGA - 40 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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	Regorafenib
D.3.4	Pharmaceutical form	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	Regorafenib
D.3.9.1	CAS number	755037-03-7
D.3.9.2	Current sponsor code	IMP2
D.3.9.4	EV Substance Code	SUB73090
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	No

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

unresectable metastatic GIST

GIST metastatico non resecabile

E.1.1.1

Medical condition in easily understood language

gastrointestinal stromal tumour (GIST -, a cancer of the stomach and bowel) that has spread and cannot be surgically removed

tumore stromale gastrointestinale (GIST ¿ tumore dello stomaco e dell¿intestino) che si ¿ diffuso e non pu¿ essere asportato chirurgicamente

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	10051066
E.1.2	Term	Gastrointestinal stromal tumour
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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10062427
E.1.2	Term	Gastrointestinal stromal tumor
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	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 determine if an alternating regimen of imatinib and
regorafenib has sufficient activity and safety to warrant further
evaluation as a first line treatment for metastatic GIST.

Determinare se un regime che preveda l¿alternanza di imatinib e regorafenib abbia sufficiente attivit¿ e sicurezza da meritare ulteriore valutazione come prima linea di trattamento per il GIST metastatico

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. Adults (over 18 yrs) with histologically confirmed GIST. In CD-117-negative cases DOG-1 must be positive or a KIT/PDGFRA mutation must be present.
2. Unresectable, metastatic disease.
3. No prior TKI for metastatic disease, with the exception of those patients who have had up to 21 days of uninterrupted treatment on 400mg daily of imatinib.
4. Imatinib therapy given as an adjuvant treatment and completed at least 3 months prior to entry into this trial is permitted. Patients who have progression of GIST while on adjuvant therapy are not eligible for this trial.
5. ECOG performance status 0-2
6. Measurable disease by RECIST version 1.1. (Note: Participants with only peritoneal disease will be eligible only if they have lesions measurable in two dimensions and have at least 1 lesion
which is = 2 cm in size).
7. Adequate bone marrow function (Haemoglobin = 9.0g/dL, platelet count = 100 x 109/L, and absolute neutrophil count = 1.5 x 109/L).
8. Adequate liver function (Serum total bilirubin =1.5 x ULN, INR = 1.5, and ALT, AST, ALP =2.5 x ULN (= 5 x ULN for participants with liver metastases). Lipase level must be = 1.5 x ULN.
9. Adequate renal function (Creatinine clearance > 50ml/min) based on either the Cockcroft Gault formula, 24 hour urine or Glomerular Filtration Rate (GFR scan); and serum creatinine = 1.5 x ULN.
10. Tumour tissue available for central review.
11. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments.
12. Study treatment both planned and able to start within 14 days of randomisation.
13. Signed, written informed consent.

1. Adulti (età uguale o maggiore di 18 anni) con GIST confermato istologicamente. Nei casi di GIST CD117-negativo, DOG-1 deve essere positivo o deve essere presente una mutazione di KIT o di PDGFRA.
2. Malattia metastastica, non operabile.
3. Nessun precedente trattamento con inibitore di tirosina chinasi per la malattia metastatica, con l’eccezione di quei pazienti che hanno iniziato un trattamento con imatinib alla dose di 400 mg al giorno da non più di 21 giorni.
4. E’ ammessa precedente terapia adiuvante con Imatinib, la quale deve essere stata completata almeno 3 mesi prima dell’ingresso in studio. I pazienti che presentano progressione di malattia in corso di terapia adiuvante non sono eleggibili allo studio.
5. Performance status ECOG 0-2.
6. Malattia misurabile secondo RECIST versione 1.1. (Nota: I soggetti con sola malattia peritoneale sono eleggibili solamente se hanno lesioni misurabili in due dimensioni di cui almeno una lesione abbia dimensioni = 2 cm).
7. Adeguata riserva midollare (emoglobina = 9.0g/dL, conta piastrinica = 100 x 109/L, e conta assoluta di neutrofili = 1.5 x 109/L).
8. Adeguata funzione epatica (Bilirubina sierica totale =1.5 x ULN, INR = 1.5, e ALT, AST, ALP =2.5 x ULN (= 5 x ULN per i pazienti con metastasi epatiche). Valore delle lipasi deve essere = 1.5 x ULN.
9. Adeguata funzione renale (clearance della creatinina > 50ml/min) mediante la formula di Cockcroft Gault, oppure la velocità di filtrazione glomerulare misurata nelle urine delle 24 ore; e creatinina sierica = 1.5 x ULN.
10. Disponibilità di campione tumorale per la revisione centralizzata.
11. Volontà e capacità di aderire alle procedure dello studio, incluse le tempistiche del trattamento e/o la natura delle valutazioni richieste.
12. Pianificazione e inizio del trattamento entro 14 giorni dalla randomizzazione.
13. Firma di consenso informato scritto.

E.4

Principal exclusion criteria

1. Concurrent GI illness which may prevent absorption of imatinib or regorafenib – please note that prior gastrectomy or bowel resection does not exclude patients from this study.
2. Use of other investigational drugs within 4 weeks prior to enrolment.
3. Known sensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
4. Participants receiving therapeutic doses of warfarin.
5. Presence of brain metastases.
6. The presence of PDGFR D842V mutation or other mutation known to cause imatinib resistance.
7. Inability to swallow tablets.
8. Arterial thrombotic or ischaemic events, such as cerebrovascular accident or pulmonary embolism within 6 months prior to randomisation; or major venous thrombotic events requiring use of an anticoagulant such as warfarin within 6 months prior to randomisation.
9. Poorly controlled hypertension (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or non healing wound, ulcer or fracture.
11. Congestive cardiac failure (NYHA = grade 2), unstable angina or new onset angina within the previous 3 months, or AMI within the previous 6 months. Cardiac arrhythmias requiring antiarrhythmic
therapy (beta blockers or digoxin are permitted).
12. Haemorrhage or bleeding event = Grade 3 according to CTCAE v4.0 within 4 weeks prior to randomisation.
13. Ongoing infection of > Grade 2 according to CTCAE v4.0.
14. Active hepatitis B or C or HIV, or chronic hepatitis B or C requiring treatment with antiviral therapy. Testing for these is not mandatory unless clinically indicated.
15. Interstitial lung disease with ongoing signs and symptoms.
16. Persistent proteinuria of = Grade 3 (>3.5g/24 hours) according to CTCAE v4.0
17. Other significant medical or psychiatric condition judged by the investigator to interfere with protocol requirements.
18. Use of biological response modifiers such as granulocyte colony stimulating factor (G-CSF), within 3 weeks prior to randomisation.
19. Patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinovir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg carbamazepine, phenobarbitol, phenytoin, rifampicin, St John’s wort).
20. History of another malignancy within 5 years prior to registration. Patients 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.
Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
21. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a
negative pregnancy test done within 7 days prior to registration. Women of childbearing potential and men must agree to use adequate contraception before entering the trial until at
least 8 weeks after the last study drug administration.

1. Concomitanti patologie gastroenteriche che possano impedire l’assorbimento di imatinib o regorafenib – una precedente gastrectomia o resezione intestinale non costituisce criterio di esclusione.
2. Utilizzo di altri farmaci sperimentali entro 4 settimane prima dell’arruolamento.
3. Ipersensibilità nota ai farmaci in studio, alle classi di farmaci in studio, o eccipienti delle formulazioni.
4. Soggetti che assumono dosi terapeutiche di warfarina.
5. Presenza di metastasi cerebrali.
6. Presenza di mutazione D842V di PDGFR o altre mutazioni note per causare resistenza ad imatinib.
7. Incapacità a deglutire compresse. to swallow tablets.
8. Eventi trombotici o ischemici arteriosi, quali eventi cerebrovascolari oppure tromboembolie polmonari nei 6 mesi precedenti la randomizzazione; oppure eventi tromboembolici venosi maggiori che richiedono utilizzo di anticoagulazione come ad esempio warfarina nei 6 mesi precedenti la randomizzazione.
9. Ipertensione scarsamente controllata (pressione sistolica > 140 mmHg oppure diastolica > 90 mmHg nonostante il miglior trattamento medico)
10. Procedura di chirurgia maggiore, biopsia aperta, o evento traumatico maggiore nei 28 giorni precedenti la randomizzazione, o presenza di ferite, ulcere o fratture che non guariscono.
11. Scompenso cardiaco (classe NYHA = 2), angina instabile oppure angina di recente insorgenza nei precedenti 3 mesi, oppure IMA nei precedenti 6 mesi. Aritimie cardiache che richiedono terapia antiaritmica (è permesso uso di beta-bloccanti o digossina).
12. Emorragia o sanguinamento di grado = 3 secondo i CTCAE v4.0 nelle 4 settimane precedenti la randomizzazione.
13. Eventi infettivi concomitanti di grado > 2 secondo i CTCAE v4.0.
14. Epatite B o C attiva, oppure HIV, oppure epatite B o C cronica che richiede terapia antivirale. Non è obbligatorio effettuare test per tali patologie se non clinicamente indicato.
15. Interstiziopatie polmonari con sintomi o segni presenti.
16. Protenuria persistente di grado = 3 (>3.5g/24 ore) secondo i CTCAE v4.0.
17. Altre condizioni mediche o psichiatriche di rilievo a giudizio dello sperimentatore che possano interferire con le procedure dello studio.
18. Utilizzo di modificatori della risposta biologica come ad esempio i fattori di crescita emopoietici (G-CSF), nelle 3 settimane precedenti la randomizzazione.
19. I pazienti che assumono farmaci che sono forti inibitori del citocromo P (CYP) CYP3A4 (esempio claritromicina, indinavir, itraconazolo, ketoconazolo, nefazodone, nelfinavir, posaconazolo, ritonavir, saquinovir, telitromicina, voriconazolo) o forti induttori del CYP3A4 (esempio carbamazepina, fenobarbital, fenitoina, rifampicina, erba di san giovanni).
20. Storia di altra neoplasia nei 5 anni precedenti. I pazienti con pregresso carcinoma in situ, carcinoma a cellule basali della cute, carcinoma squamoso della cute, o carcinoma a cellule transizionali superficiale della vescica sono eleggibili. I pazienti con storia di altra neoplasia che siano liberi da malattia da oltre 5 anni dopo trattamento definitivo sono eleggibili.
21. Gravidanza, allattamento, o assenza di contraccezione adeguata. Le donne devono essere in post-menopausa, non fertilit, oppure utilizzare metodi anticoncezionali affidabili. Le donne in età fertile devono avere un test di gravidanza negativo entro 7 giorni dalla registrazione. Le donne in età fertile e gli uomini devono acconsentire ad utilizzare adeguati metodi contraccettivi prima di entrare in studio e per almento 8 settimane dopo il termine dell’assunzione del farmaco in studio.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival

E.5.1.1

Timepoint(s) of evaluation of this end point

Progression free survival will be assessed 8 weekly for the first 12 months of treatment and thereafter 12 weekly until 24 months of treatment.

E.5.2

Secondary end point(s)

- Objective tumour response rate at 2 cycles after randomisation
- Clinical benefit rate (SD + PR + CR) following 2 cycles of treatment
- Complete response rate
- Time to treatment failure
- Safety/toxicity/tolerability
- Overall survival

- Tasso di risposta obiettiva dopo 2 cicli dalla randomizzazione;
- Tasso di beneficio clinico (malattia stabile + risposta parziale + risposta completa) dopo 2 cicli di trattamento;
- Tasso di risposta completa;
- Tempo al fallimento terapeutico;
- Sicurezza/tossicit¿/tollerabilit¿;
- Sopravvivenza globale

E.5.2.1

Timepoint(s) of evaluation of this end point

Objective tumour response rate and clinical benefit rate will assessed
every 8 weeks until 16 weeks from randomization.
Time to treatment failure, overall survival, complete response rate and
safety will be assessed 8 weekly for the first 12 months of treatment and
thereafter 12 weekly until 24 months of treatment.

Il tasso di risposta obiettiva e il beneficio clinico verranno valutati ogni 8 settimane sino a 16 settimane dalla randomizzazione.
Il tempo a fallimento terapeutico, la sopravvivenza globale, il tasso di risposta completa e la sicurezza verranno valutate ogni 8 settimane per i primi 12 mesi di trattamento e successivamente ogni 12 settimane sino a 24 mesi di trattamento.

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

Yes

E.6.13.1

Other scope of the trial description

Translational research

Ricerca traslazionale

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Hong Kong

Singapore

Denmark

Finland

France

Italy

Netherlands

Norway

Slovakia

Spain

Sweden

United Kingdom

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

Study End occurs when all of the following criteria have been satisfied:
1. thirty days have elapsed after all patients have stopped Protocol treatment
2. the trial is ready for the analysis of the primary endpoint as defined in the Protocol
3. the database has been fully cleaned and frozen for this analysis.
There are no study specific procedures foreseen after the end of trial but patients may continue visits to their treating physician in the frame of standard of care.

La sperimentazione si conclude quando ciascuno dei seguenti criteri sia stato soddisfatto: 1. Siano trascorsi 30 giorni dopo che tutti i pazienti hanno concluso il Protocollo; 2. Lo studio ¿ pronto per l¿analisi dell¿endpoint primario come definito nel Protocollo; 3. Il database ¿ stato completamente pulito e chiuso per l¿analisi. Non sono previste specifiche procedure dopo la conclusione dello studio, ma i pazienti possono proseguire le visite presso il medico curante nell¿ambito della normale

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

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

210

F.4.2.2

In the whole clinical trial

240

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)

Treatment after discontinuation of study treatment is at the discretion of the patient's clinician.
In addition, Bayer will provide regorafenib to study participants for as long as they receive benefit from the treatment until local reimbursement after the completion of the study.

Il trattamento dopo la conclusione dello studio ¿ a discrezione del medico referente per il paziente. Inoltre, Bayer fornir¿ regorafenib ai partecipanti allo studio fintantoch¿ traggono un beneficio dal trattamento sino a che il farmaco non divenga rimborsabile a livello locale dopo la conclusione dello studio.

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

2016-06-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-18

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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