ICH GCP - EU Clinical trials Registry - 2016-000259-28 (ES)

Summary
EudraCT Number:	2016-000259-28
Sponsor's Protocol Code Number:	54179060LYM3003
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:	2016-08-05
Trial results	View 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

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen Research & Development, LLC
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	Janssen-Cilag S.A
B.5.2	Functional name of contact point	Global Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Paseo de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34917228100
B.5.5	Fax number	+34917228628
B.5.6	E-mail	agonza45@its.jnj.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	Imbruvica
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EMA/OD/116/13
D.3 Description of the IMP
D.3.1	Product name	Ibrutinib
D.3.2	Product code	JNJ-54179060
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	Ibrutinib
D.3.9.1	CAS number	936563-96-1
D.3.9.2	Current sponsor code	JNJ-54179060
D.3.9.3	Other descriptive name	IBRUTINIB
D.3.9.4	EV Substance Code	SUB120863
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	140
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	Yes
D.2.1.1.1	Trade name	Imbruvica
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Ibrutinib
D.3.2	Product code	JNJ-54179060
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Yes
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	Ibrutinib
D.3.9.1	CAS number	936563-96-1
D.3.9.2	Current sponsor code	JNJ-54179060
D.3.9.3	Other descriptive name	IBRUTINIB
D.3.9.4	EV Substance Code	SUB120863
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	70
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	Yes
D.2.1.1.1	Trade name	imbruvica
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Ibrutinib
D.3.2	Product code	JNJ-54179060
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	Ibrutinib
D.3.9.1	CAS number	936563-96-1
D.3.9.2	Current sponsor code	JNJ-54179060
D.3.9.3	Other descriptive name	IBRUTINIB
D.3.9.4	EV Substance Code	SUB120863
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Mature B-Cell Neoplasm

Neoplasma Células-B Maduras

E.1.1.1

Medical condition in easily understood language

Mature B-Cell Cancer

Cáncer Células-B Maduras

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	19.0
E.1.2	Level	HLGT
E.1.2	Classification code	10025320
E.1.2	Term	Lymphomas non-Hodgkin's B-cell
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part 1:
Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults

Part 2:
Assess efficacy (EFS) of ibrutinib in combination with RICE or RVICI background therapy compared to RICE or RVICI background therapy alone

Parte 1:
Confirmar que la farmacocinética en los sujetos pediátricos es consistente con la de adultos

Parte 2:
• Evaluar la seguridad de ibrutinib combinado con (RICE) o (RVICI) como tratamiento de base en sujetos pediátricos con neoplasias malignas de células B

E.2.2

Secondary objectives of the trial

Part 1:
-Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in pediatric subjects with B-cell malignancies
-Assess anti-tumor activity of ibrutinib as add-on to RICE or RVICI regimens
-Assess disease-specific biomarkers
-Assess the pharmacodynamic response
-Acceptability and palatability assessment of all ibrutinib formulations

Part 2:
-Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in pediatric subjects and young adults with B-cell malignancies
-Determine the ORR
-Evaluate tumor volume reduction at Day 14
-Determine the number and proportion of subjects who proceed to stem cell transplantation
-Evaluate the time to response
-Measure the duration of response
-Evaluate long-term survival (EFS at 2 and 3 years)
-Evaluate overall survival
-Assess disease-specific biomarkers
For the remaining secondary objectives, please refer to protocol page 28.

P1: Evaluar
-La seguridad y tolerabilidad de ibrutinib combinado con (RICE) o (RVICI) como tratamiento de base en sujetos pediátricos con neoplasias malignas de células B
-La actividad antitumoral de ibrutinib como tratamiento complementario a los regímenes de RICE o RVICI
-Los biomarcadores específicos de la enfermedad
-La respuesta farmacodinámica
- Valoración de la aceptabilidad y palatabilidad de todas las formulaciones de ibrutinib
P2: Evaluar
-La seguridad y tolerabilidad de ibrutinib combinado con tratamiento de base con RICE o RVICI en sujetos pediátricos y adultos jóvenes con neoplasias de linfocitos B
-Determinar tasa respuesta global (TRG)
-Reducción del volumen tumoral el Día 14
-Determinar el número y proporción de sujetos que pasan a trasplante de células madre
-El tiempo hasta la respuesta
-Medir la duración de la respuesta
-Supervivencia a largo plazo (SLE a 2 y 3 años)
-Supervivencia global
-Niomarcadores específicos de la neoplasia
Otro, ref. Pág.28

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Participants with 1 to less than (<) 18 years of age (Part 1 only), or 1 to 30 years of age, inclusive, if initial diagnosis of mature B-cell non-Hodgkin lymphoma (NHL) occurred at <18 years of age (Part 2 only)
- Participants must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
- Participants must have at least 1 of the following: 1 site of measurable disease greater than (>) 1 centimeter (cm) in the longest diameter by radiological imaging; bone marrow involvement; cerebrospinal fluid with blasts present
- Participants with lansky-Karnofsky score of greater than or equal to (>=) 50
- Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening before enrollment/randomization. Adolescent/young women who are pregnant or breastfeeding are ineligible for this study

-Participantes de 1 a <18 años (Parte 1 solo), o de 1 a 30 años, inclusive, si el diagnóstico inicial de LNH de linfocitos B maduros fue antes de los 18 años (Parte 2 solo)

-Participante debe estar en la primera recurrencia o posteriores o tener una neoplasia que sea intrínsecamente resistente al tratamiento convencional
- Participante debe presentar al menos 1 de los siguientes:
1) sitio de neoplasia mensurable >1 cm de diámetro mayor en una prueba de imagen radiológica
2) Afectación de la médula ósea
3)Blastos en el líquido cefalorraquídeo
-Puntuación Lansky-Karnofsky de ≥50
-Las mujeres adolescentes/jóvenes con posibilidad de concebir se realizarán una prueba de embarazo de  gonadotropina corinónica humana ( hCG) de alta sensibilidad en suero u orina que debe dar negativo en la Selección antes de la inclusión/aleatorización. Las mujeres adolescentes/jóvenes embarazadas o que estén dando el pecho no son elegibles para este estudio.

E.4

Principal exclusion criteria

- Participants with ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in Section 8.2, Prohibited Medications, before the planned first dose of study drug
- Participants with inherited or acquired bleeding disorders
- Participants with clinically significant arrhythmias, complex congenital heart disease, or left ventricular ejection fraction (LVEF) <50 percent (%) or shortening fraction (SF) <=28%
- Participants with known history of human immunodeficiency virus (HIV) or active Hepatitis B or C virus
- Participants with any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
- Participants with known allergies, hypersensitivity, or intolerance to ibrutinib or its excipients (refer to Investigator's Brochure)

-Tratamiento actual con anticoagulantes como warfarina o antagonistas equivalentes de la vitamina K (por ejemplo fenprocoumon), o tratamiento actual con productos que son inhibidores potentes de CYP3A4/5, o cualquier tratamiento no permitido como se indica en la Sección 8.2, Medicación prohibida, antes de la primera dosis prevista del fármaco del estudio -Trastornos de la coagulación hereditarios o adquiridos -Arritmias clínicamente significativas, cardiopatía congénita compleja o fracción de eyección ventricular izquierda (FEVI) < 50 % o fracción de acortamiento (FA) ≤ 28 % -Antecedentes conocidos de (VIH) o virus de la hepatitis B o C activos -Cualquier afección que pueda interferir con la absorción o el metabolismo de ibrutinib como síndrome de malabsorción, enfermedad que afecte significativamente a la función gastrointestinal o resección de estómago o intestino delgado -Alergias conocidas, hipersensibilidad o intolerancia a ibrutinib o a sus excipientes (ref M. del investigador)

E.5 End points

E.5.1

Primary end point(s)

1/ Part 1: Area Under The Plasma Concentration-Time Curve (Auc) of Ibrutinib
2/ Part 1: Apparent (oral) Plasma Clearance (CL/F) of Ibrutinib
3/ Part 1: Apparent (oral) Volume of Distribution (Vd/F) of Ibrutinib
4/ Part 1: Maximum Observed Plasma Concentration (Cmax)
5/ Part 1: Relationship Between Pharmacokinetic Parameters and Age or Measure of Body Size
6/ Part 2: Event-free Survival [EFS]) of Ibrutinib

1/Parte 1: Área bajo la concentración plasmática-tiempo de curva (AUC) de Ibrutinib
2/Parte 1: Aparente (oral) aclaramiento plasmático de Ibrutinib (CL/F)
3/Parte 1: Volumen aparente (oral) de distribución de Ibrutinib (Vd/F)
4/Part 1: Concentración plasmática máxima observada (Cmax)
5/Parte 1: Relación entre los parámetros farmacocinéticos la edad o la medida del tamaño corporal
6 / Parte 2: Evento de supervivencia libre de Ibrutinib [EFS])

E.5.1.1

Timepoint(s) of evaluation of this end point

1-4 /Predose and at 1, 2, 4, and 6 hours postdose on Day 1 and on Day 7 or 8 of cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3.
5/ up to three 28-day cycles
6/ Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (approximately 4.2 years)

1-4 /Antes de la dosis, a las 1, 2, 4, y 6 horas después de la dosis en el día 1 y el día 7 o 8 del ciclo 1; antes de la dosis, 1, 2, 4, y 6 horas después de la dosis en el día 1 del Ciclo 2 o del Ciclo 3.
5 / Hasta tres ciclos de 28 días
6 / La asignación, al azar hasta la muerte, progresión de la enfermedad, o la falta de RC o RP después de 3 ciclos de tratamiento (aproximadamente 4.2 años)

E.5.2

Secondary end point(s)

1/ Part 1: Number of Participants with Adverse Events
2/ Part 1: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR)
3/ Part 1: Disease-specific Biomarkers Assessment
4/ Part 1: Bruton’s tyrosine kinase (BTK) Percent Occupancy
5/ Part 1: Visual analog Scale Score for Palatability
6/ Part 2: Number of Participants with Adverse Events
7/ Part 2: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR)
8/ Part 2: Tumor Volume Reduction
9/ Part 2: Percentage of Participants who Proceed to Stem Cell Transplantation
10/ Part 2: Time to Response
11/ Part 2: Duration of Response
12/ Part 2: Percentage of Participants with Long-term Survival
13/ Part 2: Overall Survival
14/ Part 2: Disease-specific Biomarkers Assessment
15/ Part 2: Bruton’s tyrosine kinase (BTK) Percent Occupancy
16/ Part 2: Visual analog Scale Score for Palatability
17/ Part 2: Area under the plasma concentration-time curve (AUC)

1/Parte 1: Número de participantes con eventos adversos
2/Parte 1: Porcentaje de participantes que lograr una respuesta completa (RC) y respuesta parcial (RP)
3/Parte 1: Evaluación de biomarcadores de la enfermedad-específica
4/Part 1: Tirosina quinasa de Bruton (BTK) Porcentaje de ocupación
5/Parte 1: Escala visual analógica de puntuación para palatabilidad
6/Parte 2: Número de participantes con eventos adversos
7/Parte 2: Porcentaje de participantes que logran una respuesta completa (RC) y respuesta parcial (RP)
8/Parte 2: Reducción del volumen tumoral
9/Parte 2: Porcentaje de participantes que progresan al trasplante de células madre
10/Parte 2: Tiempo hasta la respuesta
11/Parte 2: Duración de la respuesta
12/Parte 2: Porcentaje de participantes con la supervivencia a largo plazo
13/Parte 2: La supervivencia global
14/Parte 2: Evaluación de biomarcadores de la enfermedad-específica
15/ Parte 2: Tirosina quinasa de Bruton (BTK) Porcentaje de ocupación
16/Parte 2: Escala visual analógica de puntuación para palatabilidad
17/Parte 2: El área bajo la curva de concentración plasmática-tiempo (AUC)

E.5.2.1

Timepoint(s) of evaluation of this end point

1/ Throughout the study duration (approx up to 4.2yrs)
2/ Treatment Phase:D14 (Cy1),end of Cy2,EOT visit;Post treatment phase:every 12wks for first 12m,every 6m until PD/clinical cutoff for primary endpoint/or upto 2yrs after last subject enrolled,whichever occurs first
3/ Cy1 D1, Cy2 D1, Cy3 D1&EOT visit
4/ 4 hrs postdose on D1 and D7 or 8 of Cy1, predose on Cy2 D1 or Cy3 D1, and the EOT visit
5/ Cy1 D1&y3 D1
6/ Throughout the study duration (approx up to 4.2yrs)
7/ idem timepoint nbr 2
8/ D14
9/ Cy2 (D28)
10-11/ Up to 4.2yrs
12/ 2, 3yrs
13/ Randomization to the date of death (maximum up to 4.2yrs)
14/ Cy1 D1, Cy2 D1, Cy3 D1 and EOT visit
15-16/ Cy1 D1 & Cy3 D1
17/ Predose; 1, 2, and 4 hrs postdose, either on D7 or 8 of Cy1 or on D1 of Cy2 (or Cy3)

1/A lo largo de la dur. del estud. (aprox. hasta 4.2a.)
2/Fase de Trat.: D14 (Cy1), final de Cy2, visita EOT; fase de trat. post: cada 12s. dur. los 12 primeros m, cada 6m. hasta corte clinico de la 1ª variable, hasta 2 a. desp. últ. pac. inscrito, lo que ocurra primero
3/Cy1 D1, D1 Cy2, Cy3 D1 y EOT visita
4/4 h. desp. de la dosis en D1 y D7 u 8 de Cy1, antes de la dosis en Cy2 D1 o D1 Cy3, y la visita EOT
5/Cy1 D1 y D1 y3
6/A lo largo de la dur. del estud. (aprox hasta 4.2a)
7/Idem punto de tiempo de 2 NBR
8/D14
9/Cy2 (D28)
10-11/Hasta 4.2a.
12/2,3 a.
13/La aleatorización hasta la fecha de la muerte (máx. hasta 4.2a.)
14/Cy1 D1, D1 Cy2, Cy3 D1 y EOT vis
15-16/Cy1 D1 y D1 Cy3
17/antes de la dosis; 1, 2, y 4 h. desp. de la dosis, ya sea en D7 o 8 de Cy1 o en D1 de Cy2 (o Cy3)

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

Yes

E.6.7

Pharmacodynamic

Yes

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

Biomarker analysis

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

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

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

Yes

E.8.2.3.1

Comparator description

Background Chemoimmunotherapy

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

Argentina

Belgium

Brazil

Bulgaria

Canada

China

Czech Republic

France

Germany

Hungary

Italy

Japan

Mexico

Netherlands

Poland

Romania

Russian Federation

Spain

Switzerland

Taiwan

Turkey

Ukraine

United Kingdom

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 end of study is defined as when approximately 60 EFS events have occurred in Part 2 (death, disease progression, or lack of CR or PR after 3 cycles of treatment based on blinded independent event review), or the sponsor terminates the study, whichever comes first.

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

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-11

임상 시험 Nct 페이지

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