Clinical Trials Register

Summary
EudraCT Number:	2018-000635-27
Sponsor's Protocol Code Number:	2002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-08-24
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-000635-27

A.3

Full title of the trial

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Brigatinib en pacientes con cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+) cuyo cáncer ha progresado durante el tratamiento con alectinib o ceritinib

A.3.1

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

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

A.4.1

Sponsor's protocol code number

2002

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	ARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
B.1.3.4	Country	United States
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	ARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Takeda Pharmaceuticals Inc.
B.5.2	Functional name of contact point	Ashwata Pokhrel
B.5.3	Address:
B.5.3.1	Street Address	40 Landsdowne Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02139
B.5.3.4	Country	United States
B.5.4	Telephone number	900 811 335
B.5.5	Fax number	+1617551 3742
B.5.6	E-mail	ashwata.pokhrel@takeda.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	Brigatinib
D.3.2	Product code	AP26133
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	Brigatinib
D.3.9.1	CAS number	1197953-54-0
D.3.9.2	Current sponsor code	AP26113
D.3.9.3	Other descriptive name	AP26113
D.3.9.4	EV Substance Code	SUB32682
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	90
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	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	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	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	Brigatinib
D.3.2	Product code	AP26133
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	Brigatinib
D.3.9.1	CAS number	1197953-54-0
D.3.9.2	Current sponsor code	AP26113
D.3.9.3	Other descriptive name	AP26113
D.3.9.4	EV Substance Code	SUB32682
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	180
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	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	No
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	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	Brigatinib
D.3.2	Product code	AP26133
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	Brigatinib
D.3.9.1	CAS number	1197953-54-0
D.3.9.2	Current sponsor code	AP26113
D.3.9.3	Other descriptive name	AP26113
D.3.9.4	EV Substance Code	SUB32682
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	180
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Brigatinib
D.3.9.1	CAS number	1197953-54-0
D.3.9.2	Current sponsor code	AP26113
D.3.9.3	Other descriptive name	AP26113
D.3.9.4	EV Substance Code	SUB32682
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	30
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	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	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-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC)

Cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+)

E.1.1.1

Medical condition in easily understood language

Metastatic or locally advanced non-small cell lung cancer

Cáncer de pulmón de células no pequeñas metastático o localmente avanzado

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	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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 the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib as determined by investigator.

Determinar la eficacia de brigatinib, demostrada mediante la tasa de respuesta objetiva (TRO) confirmada, en pacientes con CPCNP ALK+, localmente avanzado o metastásico, cuya enfermedad ha progresado durante el tratamiento con alectinib o ceritinib, según la determinación del investigador.

E.2.2

Secondary objectives of the trial

1. To characterize the durability of efficacy with brigatinib.
2. To assess intracranial efficacy of brigatinib.
3. To assess the overall survival (OS).
4. To assess the safety and tolerability of brigatinib.
5. To collect plasma concentration-time data for brigatinib to contribute to population pharmacokinetic analyses.
6. To assess patient-reported symptoms and health-related quality of life (HRQOL).

1. Caracterizar la durabilidad de la eficacia con brigatinib.
2. Evaluar la eficacia intracraneal de brigatinib.
3. Evaluar la supervivencia global (SG).
4. Evaluar la seguridad y tolerabilidad de brigatinib.
5. Recopilar datos de concentración plasmática frente al tiempo de brigatinib para contribuir a los análisis de farmacocinética poblacional.
6. Evaluar los síntomas notificados por el paciente y la calidad de vida relacionada con la salud (CdVRS).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non–small-cell lung cancer (NSCLC).
2. Must meet both of the following 2 criteria:
a. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non–FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
b. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
3. Had progressive disease (PD) while on alectinib or ceritinib
4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade =1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
7. Have a life expectancy of ≥3 months.

1. Tener CPCNP en estadio IIIB (localmente avanzado o recurrente y que no sea candidato a un tratamiento con intención curativa) o estadio IV, confirmado mediante histología o citología.
2. Debe cumplir los 2 criterios siguientes:
a) Tener documentación del reordenamiento de ALK mediante un resultado positivo de cualquier prueba de laboratorio aprobada por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) o tener reordenamiento de ALK documentado mediante una prueba diferente (pruebas del laboratorio local no aprobadas por la FDA) y ha proporcionado muestra tumoral al laboratorio central. (Nota: no es necesario obtener los resultados del análisis de reordenamiento de ALK del laboratorio central antes de la aleatorización).
b) El paciente había recibido tratamiento con uno de los inhibidores de la tirosina quinasa ALK (TKI) (alectinib, ceritinib, crizotinib) durante al menos 12 semanas antes de la progresión.
3. Presentó progresión de la enfermedad mientras recibía alectinib o ceritinib.
4. Recibió alectinib o ceritinib como el tratamiento inhibidor de ALK más reciente.
5. Tiene al menos 1 lesión medible según RECIST versión 1.1, evaluada por el investigador.
6. Se ha recuperado de las toxicidades relacionadas con el tratamiento antineoplásico previo, según los Criterios terminológicos comunes para acontecimientos adversos del Instituto Nacional del Cáncer, versión 4.03, Grado =1. (Nota: la alopecia o la neuropatía periférica relacionadas con el tratamiento que sean de un grado >1 se permiten si se consideran irreversibles) y tiene una función adecuada de los órganos principales.
7. Tiene una esperanza de vida ≥ 3 meses.

E.4

Principal exclusion criteria

1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
2. Had received both alectinib and ceritinib.
3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

1. Ha recibido algún TKI previo dirigido contra ALK que no sea crizotinib, alectinib o ceritinib.
2. Ha recibido tanto alectinib como ceritinib.
3. Ha recibido anteriormente más de 3 pautas de tratamiento antineoplásico sistémico para la enfermedad localmente avanzada o metastásica.
4. Tiene metástasis cerebral sintomática (parenquimatosa o leptomeníngea). Puede inscribirse a pacientes con metástasis cerebral asintomática o que tengan síntomas estables que no requieran un aumento de la dosis de corticosteroides para controlar los síntomas en los últimos 7 días antes de la primera dosis de brigatinib.
5. Tiene compresión medular actual (sintomática o asintomática, detectada por imágenes radiográficas). Se permiten participantes con enfermedad leptomeníngea y sin compresión de la médula.
6. Tuvo un accidente cerebrovascular o un ataque isquémico transitorio dentro de los 6 meses antes de la primera dosis de brigatinib.
7. Tiene una infección activa o en curso, que incluye, entre otros, requisito de antibióticos por vía intravenosa.
8. Síndrome de malabsorción u otra enfermedad gastrointestinal (GI) que podría afectar la absorción oral de brigatinib.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is confirmed ORR, as assessed by the IRC, per Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1 in the full analysis set population.

El criterio de valoración principal es la TRO confirmada, evaluada por el comité de revisión independiente (CRI), de acuerdo con los criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, en la población del grupo completo de análisis.

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall timeframe will be pending on final sample size.

El periodo general dependerá del tamaño de muestra final.

E.5.2

Secondary end point(s)

1. Confirmed ORR, as assessed by the investigator, per RECIST version 1.1.
2. DOR as assessed by the investigator and IRC.
3. PFS as assessed by the investigator and IRC.
4. Disease control rate (DCR), defined as best overall response of complete response (CR), partial response (PR) or
stable disease (SD) ≥6 weeks by RECIST version 1.1, as assessed by the investigator and IRC.
5. Time to response as assessed by the investigator and IRC.
6. Confirmed iORR in patients with brain metastases at baseline, as assessed by the IRC.
7. Duration of intracranial response in patients with brain metastases at baseline, as assessed by the IRC.
8. Intracranial progression-free survival (iPFS) in patients with brain metastases at baseline, as assessed by the IRC.
9. OS.
10. Safety/tolerability (CTCAE version 4.03).
11. HRQOL assessed with the global health status/quality of life (QOL) and other function and symptom from EORTC QLQ-C30 (version 3.0), and EORTC QLQ-LC13.

1. TRO confirmada, evaluada por el investigador de acuerdo con RECIST versión 1.1.
2. Duración de la respuesta (DR) evaluada por el investigador y el CRI.
3. Supervivencia libre de progresión (SLP) evaluada por el investigador y el CRI.
4. Tasa de control de la enfermedad (TCE), definida como la mejor respuesta global de respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE) ≥6 semanas, según RECIST versión 1.1, evaluada por el investigador y el CRI.
5. Tiempo hasta la respuesta evaluado por el investigador y el CRI.
6. TRO intracraneal (TROi) confirmada en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
7. Duración de la respuesta intracraneal en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
8. Supervivencia libre de progresión intracraneal (SLPi) en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
9. SG.
10. Seguridad/tolerabilidad (CTCAE versión 4.03).
11. La CdVRS se evaluará con el estado de salud/calidad de vida (CdV) a nivel global y otras funciones y síntomas del EORTC QLQ-C30 (versión 3.0) y EORTC QLQ-LC13.

E.5.2.1

Timepoint(s) of evaluation of this end point

Overall timeframe will be pending on final sample size.

El periodo general dependerá del tamaño de muestra final.

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

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

To evaluate exploratory biomarkers

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.8.2.4

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

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

Austria

Canada

China

France

Germany

Hong Kong

Israel

Italy

Korea, Republic of

Netherlands

Spain

Sweden

Taiwan

United States

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

The study will end when either all patients die or 3 years have passed since the last patient started study treatment, whichever comes first.

El estudio terminará cuando o bien todos los pacientes hayan fallecido o cuando hayan pasado 3 años desde que el primer paciente empezó el tratamiento del estudio, lo que suceda antes.

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

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

103

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 will continue to be treated with brigatinib until they experience objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity. With medical monitor approval, treatment may be continued at 180 mg QD or may be escalated to 240 mg QD after initial progression if there is still potential for clinical benefit.

Los pacientes seguirán recibiendo tratamiento con brigatinib hasta que experimenten una progresión objetiva de la enfermedad, evaluada por el investigador de acuerdo con RECIST versión 1.1, o una toxicidad intolerable. En caso de que potencialmente puedan seguir beneficiándose del tratamiento, tras la progresión inicial se puede continuar el tratamiento a 180 mg o se puede aumentar a 240 mg con aprobación del supervisor médico

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

2018-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-08

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

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