Clinical Trials Register

Summary
EudraCT Number:	2017-000207-24
Sponsor's Protocol Code Number:	BO39694
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-24
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

2017-000207-24

A.3

Full title of the trial

A MULTICENTER, INTERNATIONAL, ROLLOVER STUDY OF ALECTINIB IN PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE OR REARRANGED DURING TRANSFECTION (RET)-POSITIVE CANCER

STUDIO DI ESTENSIONE MULTICENTRICO E INTERNAZIONALE SU ALECTINIB IN PAZIENTI AFFETTI DA CARCINOMA POSITIVO PER LA CHINASI DEL LINFOMA ANAPLASTICO (ALK) O PER IL GENE RET (REARRANGED DURING TRANSFECTION)

A.3.1

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

A Rollover Study of Alectinib in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Uno Studio di rollover di Alectinib in pazienti con CARCINOMA POSITIVO PER LA CHINASI DEL LINFOMA ANAPLASTICO (ALK) O PER IL GENE RET (REARRANGED DURING TRANSFECTION)

A.3.2

Name or abbreviated title of the trial where available

A Rollover Study of Alectinib in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive or Rearrang

Uno Studio di rollover di Alectinib in pazienti con CARCINOMA POSITIVO PER LA CHINASI DEL LINFOMA AN

A.4.1

Sponsor's protocol code number

BO39694

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	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	F. Hoffmann-La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041616881111
B.5.5	Fax number	0041616919319
B.5.6	E-mail	global.rochegenentechtrials@roche.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	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	Alectinib
D.3.2	Product code	RO5424802/F03
D.3.4	Pharmaceutical form	Capsule, hard
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	ALECTINIB
D.3.9.2	Current sponsor code	RO5424802
D.3.9.3	Other descriptive name	ALK INHIBITOR
D.3.9.4	EV Substance Code	SUB178557
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	150
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	Comparator
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	XALKORI - 250 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) - 60 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
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	Xalkori
D.3.4	Pharmaceutical form	Capsule, hard
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	00327900
D.3.9.1	CAS number	877399-52-5
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	CRIZOTINIB
D.3.9.4	EV Substance Code	SUB32267
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	250
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	XALKORI - 200 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) - 60 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
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	Xalkori
D.3.4	Pharmaceutical form	Capsule, hard
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	00327900
D.3.9.1	CAS number	877399-52-5
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	CRIZOTINIB
D.3.9.4	EV Substance Code	SUB32267
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	200
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

Anaplastic lymphoma kinase (ALK)-positive or rearranged during transfection (RET)-positive cancer

Carcinoma positivo per la chinasi del linfoma anaplastico (ALK) o per il gene RET (rearranged during transfection)

E.1.1.1

Medical condition in easily understood language

ALK positive cancer is any type of cancer that has a change in the ALK gene. RET positive cancer is any type of cancer that has a change in the RET gene.

cancro ALK positivo ¿ qualsiasi tipo di cancro che ha un cambiamento nella ALK
gene. cancro positivo RET ¿ un qualsiasi tipo di cancro che ha una variazione del
gene RET.

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	10029521
E.1.2	Term	Non-small cell lung cancer stage IIIB
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	10029522
E.1.2	Term	Non-small cell lung cancer stage IV
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 provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure

Permettere la prosecuzione del trattamento con alectinib o crizotinib in pazienti affetti da carcinoma ALK- o RET-positivo precedentemente arruolati in qualsiasi studio su alectinib promosso da Roche e che stanno ottenendo beneficio clinico continuo da alectinib o crizotinib nella sperimentazione originaria al momento della sua chiusura.

E.2.2

Secondary objectives of the trial

¿To assess long-term safety of alectinib therapy

Valutare la sicurezza a lungo termine della terapia con alectinib

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
-Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form
-Ability and willingness to comply with the protocol, in the investigator's judgment
-For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
-For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.

-Pazienti arruolati in una sperimentazione su alectinib promossa da Roche che stanno traendo beneficio clinico dal trattamento con alectinib o crizotinib al momento della discontinuazione dalla sperimentazione originaria e che non possono passare alla terapia con farmaco disponibile in commercio.
- Raccolta di informazioni sulla conclusione dello studio, tra cui dati di sicurezza ed efficacia, nella scheda di raccolta dati elettronica, come previsto dallo studio originario.
- Capacità e volontà di rispettare il protocollo, secondo il giudizio dello sperimentatore.
- Per le donne non in stato postmenopausale (>= 12 mesi di amenorrea non indotta dalla terapia) o non sottoposte a sterilizzazione chirurgica (assenza delle ovaie e/o dell’utero): consenso a praticare l’astinenza o ad adottare metodi contraccettivi singoli o combinati che garantiscano un tasso di insuccesso < 1% all’anno durante il periodo di trattamento e per almeno 3 mesi dopo l’assunzione dell’ultima dose del farmaco sperimentale. L’astinenza è accettabile soltanto se compatibile con lo stile di vita preferito e abituale della paziente. L’astinenza periodica (per es. metodo del calendario, dell’ovulazione, sintotermico o post-ovulazione) e il coito interrotto non sono ritenuti metodi contraccettivi accettabili. Esempi di metodi anticoncezionali con tasso di insuccesso < 1% all’anno includono chiusura delle tube, vasectomia, impianti contraccettivi ormonali, uso consolidato e appropriato di contraccettivi ormonali orali o iniettabili combinati, e alcuni dispositivi intrauterini.
- Per gli uomini: consenso a praticare l’astinenza o ad adottare un metodo contraccettivo che garantisca un tasso di insuccesso < 1% all’anno durante il periodo di trattamento e per almeno 3 mesi dopo l’assunzione dell’ultima dose del farmaco sperimentale. L’astinenza è accettabile soltanto se compatibile con lo stile di vita preferito e abituale del paziente. L’astinenza periodica (per es. metodo del calendario, dell’ovulazione, sintotermico o post-ovulazione) e il coito interrotto non sono ritenuti metodi contraccettivi accettabili.

E.4

Principal exclusion criteria

-Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
-Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
-Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
-Pregnant or breastfeeding women
-Ongoing serious adverse event that has not resolved to baseline level or Grade =1 prior to first dose of study treatment in the rollover study
-Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
-Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
-Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the patient before trial entry

-Evidenze di mancato beneficio clinico nella sperimentazione originaria durante la fase di screening del presente studio di estensione.
- Discontinuazione definitiva del trattamento con alectinib o crizotinib per qualsiasi ragione durante lo studio originario o prima dell’assunzione della prima dose del farmaco sperimentale nello studio di estensione.
- Evidenza di un evento avverso per il quale il protocollo originario impone la discontinuazione definitiva del trattamento.
- Donne in gravidanza o in allattamento.
- Evento avverso grave in corso che non è tornato al grado basale o non ha raggiunto un grado = 1 prima dell’assunzione della prima dose del trattamento sperimentale nello studio di estensione.
- Sospensione del trattamento per oltre 21 giorni a causa di un evento avverso dall’ultima assunzione di alectinib o crizotinib nella sperimentazione originaria. Eventuali eventi avversi in corso che richiedono la sospensione temporanea della terapia devono tornare al grado basale o essere valutati dallo Sperimentatore come stabili e non necessitanti di ulteriori sospensioni del trattamento.
- Somministrazione di forti/potenti inibitori o induttori del citocromo P450 3A nei 14 giorni precedenti all’assunzione della prima dose del trattamento durante il presente studio e nel corso della terapia con crizotinib.
- Qualsiasi condizione psicologica, familiare, sociologica o geografica che potrebbe compromettere il rispetto dei requisiti del protocollo di studio e/o delle procedure di follow-up; tali condizioni devono essere discusse con il paziente prima dell’ingresso nella sperimentazione.

E.5 End points

E.5.1

Primary end point(s)

-Not applicable

E.5.1.1

Timepoint(s) of evaluation of this end point

-Not applicable

E.5.2

Secondary end point(s)

1. Incidence of serious and non-serious adverse events and adverse events of special interest 2. Selected safety laboratory test measurements 3. Number of Deaths occurring on study

L'incidenza di eventi avversi gravi e non gravi e negativi
eventi di particolare interesse
2. La misurazione dei test di laboratorio di sicurezza selezionati
3. Numero di decessi che si verificano in studio

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3. Throughout the study

1-3. Nel corso dello studio

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

Yes

E.6.5

Efficacy

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

To provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.1.7.1

Other trial design description

studio di rollover (offrire di continuare l'opzione di trattamento in corso dallo studio originario

rollover study (to offer continious treatment option for patents from parent studies)

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

Yes

E.8.2.3.1

Comparator description

Crizotinib

Crizotinib (Xalkori)

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

Korea, Democratic People's Republic of

Korea, Republic of

Taiwan

France

Italy

Spain

Czechia

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

The study will end when the last patient has completed the safety follow-up visit 4 weeks after the last dose of study drug. Because of the nature of the study, the total length of study will not be estimated.

Lo studio terminer¿ quando l¿ultimo paziente avr¿ concluso la visita di follow-up di sicurezza 4 settimane dopo l¿assunzione dell¿ultima dose del farmaco sperimentale.

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:

168

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

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)

The sponsor does not intend to provide alectinib or crizotinib to patients upon early withdrawal or after completion of this rollover study.

Lo sponsor non intende fornire alectinib o crizotinib a pazienti con ritiro anticipato o dopo il completamento di questo studio di rollover
studia

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

2017-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-15

P. End of Trial
P.	End of Trial Status	Completed

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