Clinical Trials Register

Summary
EudraCT Number:	2013-002110-12
Sponsor's Protocol Code Number:	GO28667
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:	2014-02-27
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-002110-12

A.3

Full title of the trial

A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN
RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199)
PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB

ESTUDIO DE FASE III, ABIERTO, MULTICÉNTRICO, ALEATORIZADO EN
PACIENTES CON LEUCEMIA LINFOCÍTICA CRÓNICA
RECIDIVANTE/RESISTENTE PARA EVALUAR EL BENEFICIO DE GDC-0199
(ABT-199) MÁS RITUXIMAB EN COMPARACIÓN CON BENDAMUSTINA MÁS
RITUXIMAB.

A.3.1

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

A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB

A.4.1

Sponsor's protocol code number

GO28667

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	AbbVie Deutschland GmbH & Co. KG
B.1.3.4	Country	Germany
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	AbbVie Inc.
B.4.2	Country	United States
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	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Abbott House, Vanwall Business Park
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4XE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	441628773355
B.5.5	Fax number	441628644330
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1080
D.3 Description of the IMP
D.3.1	Product name	ABT-199 (GDC-0199)
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	ABT-199 (GDC-0199) 10 mg
D.3.9.2	Current sponsor code	ABT-199
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	10
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1080
D.3 Description of the IMP
D.3.1	Product name	ABT-199 (GDC-0199)
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	ABT-199 (GDC-0199) 50 mg
D.3.9.2	Current sponsor code	ABT-199
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	50
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1080
D.3 Description of the IMP
D.3.1	Product name	GDC-0199 (GDC-0199)
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	ABT-199 (GDC-0199) 100 mg
D.3.9.2	Current sponsor code	ABT-199
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	100
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: 4
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	MabThera®
D.2.1.1.2	Name of the Marketing Authorisation holder	F. Hoffmann ? La Roche Ltd, Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Rituximab
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.4	EV Substance Code	SUB12570MIG
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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: 5
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	Levact®
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma GmbH (distributed by Mundipharma)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Bendamustine
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
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	2.5
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

Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Leucemia Linfocítica crónica (LLC) recidivante/ resistente

E.1.1.1

Medical condition in easily understood language

Cancer of the blood and bone marrow

Cáncer de la sangre y médula ósea

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10068852
E.1.2	Term	B-cell chronic lymphocytic leukaemia
E.1.2	System Organ Class	100000004864

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

To evaluate the efficacy of GDC-0199 and rituximab (GDC-0199+R) compared with bendamustine and rituximab (BR) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) as measured by investigator-assessed progression-free survival (PFS).

Evaluar la eficacia de GDC-0199 y rituximab (GDC-0199+R) en
comparación con bendamustina y rituximab (BR) en pacientes con
Leucemia Linfocítica crónica (LLC) recidivante o resistente según la
medición de la supervivencia sin progresión (SSP) evaluada por el
investigador.

E.2.2

Secondary objectives of the trial

? To analyze Independent Review Committee (IRC) & investigator-assessed PFS in the subset of CLL patients with 17p deletion
? To evaluate PFS as assessed by an IRC.
? To evaluate rates of OR, PR, and CR and CRi at 12 weeks after Day 1 of the last cycle of multi-agent therapy.
? To evaluate OR, PR, CR, and CRi rates 12 weeks after Day 1 of the last cycle of multi-agent therapy, as determined by the IRC.
? To evaluate overall survival (OS).
? To evaluate duration of response for patients with a best overall response of CR, CRi, or PR.
? To evaluate time to next anti-CLL treatment.
? To evaluate the proportion of patients with MRD-negativity at the disease response assessment time points.

- Analizar la SSP evaluada por el comité de revisión independiente (CRI) en el subgrupo de pacientes de LLC con deleción del 17p
- Evaluar la SSP según la evaluación de un CRI
- Evaluar las tasas de RG, RP, RC y RCi 12 semanas después del día 1 del último ciclo de tratamiento con múltiples fármacos.
- Evaluar las tasas de RG, RP, RC y RCi 12 semanas después del día 1 del último ciclo de tratamiento con múltiples fármacos, según lo
determinado por el CRI
- Evaluar la supervivencia general (SG).
- Evaluar la duración de la respuesta (DR) para los pacientes con una
mejor respuesta global de RC, RCi o RP.
- Evaluar el tiempo hasta el siguiente tratamiento (TST) para la LLC.
- Evaluar la proporción de pacientes con enfermedad mínima residual
(EMR) negativa en los momentos de evaluación de la respuesta de la
enfermedad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2008).
Patients must have peripheral blood B-lymphocyte counts which clonally express CD5, CD19/20 and CD23 and are either kappa or lambda light-chain restricted.
Pro-lymphocytes may comprise no more than 55% of total circulating lymphocytes.
At initial diagnosis of CLL (ie, prior to front-line treatment), the peripheral lymphocyte count must have been >5000/mm3. Patients must meet the following criteria for relapsed or refractory CLL (per the iwCLL guidelines [Hallek et al. 2008]):
-Relapsed disease: a patient who previously achieved a CR or PR, but after a period of 6 months or more demonstrates evidence of progression;
-refractory disease: treatment failure or disease progression within 6 months of the last anti-leukemia therapy.

- Diagnóstico de LLC que cumpla los criterios diagnósticos publicados
(Hallek et al. 2008)
- Los pacientes deben tener recuentos de linfocitos B en sangre
periférica que expresen de forma clónica CD5, CD19/20 y CD23, y
presentan restricción de cadenas ligeras kappa o lambda.
- Los prolinfocitos no pueden comprender más del 55% de los linfocitos circulantes totales.
- En el momento de diagnóstico inicial de la LLC (es decir, antes del
tratamiento de primera línea), el recuento de linfocitos periféricos debe haber sido mayor de 5000/mm3. Los pacientes deben cumplir los siguientes criterios para la LLC recidivante o resistente (según las directrices del iwCLL [Hallek et al. 2008])
o Enfermedad recidivante: un paciente que logró previamente una RC o una RP, pero tras un periodo de 6 meses o más muestra signos de progresión.
o Enfermedad resistente: fracaso del tratamiento o progresión de la
enfermedad en el plazo de 6 meses desde el último tratamiento contra la leucemia.

E.4

Principal exclusion criteria

Transformation of CLL to aggressive NHL (eg, Richter's transformation, prolymphocytic leukemia, or DLBCL) or CNS involvement by CLL.

Transformación de la LLC a un LNH agresivo (p. ej.: transformación de
Richter, leucemia prolinfocítica o LMDLB) o implicación del SNC por la
LLC.

E.5 End points

E.5.1

Primary end point(s)

To evaluate the efficacy of GDC-0199 and rituximab (GDC-0199+R) compared with bendamustine and rituximab (BR) in patients with relapsed or refractory CLL as measured by investigator-assessed progression-free survival (PFS).

Evaluar la eficacia de GDC-0199 y rituximab (GDC-0199+R) en
comparación con bendamustina y rituximab (BR) en pacientes con
leucemia linfocítica crónica (LLC) recidivante o resistente según la
medición de la supervivencia sin progresión (SSP) evaluada por el
investigador.

E.5.1.1

Timepoint(s) of evaluation of this end point

September 2016 & September 2017

Septiembre 2016 y Septiembre 2017

E.5.2

Secondary end point(s)

To analyze Independent Review Committee (IRC)-assessed PFS in the subset of CLL patients with 17p deletion identified by fluorescence in situ hybridization (FISH) testing performed at a central laboratory.

Analizar la SSP evaluada por el comité de revisión independiente (CRI)
en el subgrupo de pacientes de LLC con deleción del 17p identificada
mediante la prueba de hibridación fluorescente in situ (FISH) realizada en un laboratorio central.

E.5.2.1

Timepoint(s) of evaluation of this end point

September 2017

Septiembre 2017

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Patient-Reported Outcome Objectives

Objetivos de los resultados notificados por el paciente

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

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

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

100

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

Belgium

Canada

Denmark

France

Italy

Austria

Netherlands

Sweden

Australia

Czech Republic

Finland

Germany

Hungary

Korea, Republic of

Spain

Poland

Taiwan

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 will be approximately 3 years after last patient is enrolled allowing for completion of the maximum duration of planned therapy (in the absence of disease progression) as well as at least one year of follow-up for all patients.

La finalización del estudio será aproximadamente 3 años después de la
inscripción del último paciente, lo que permite la finalización del
tratamiento planificado de duración máxima (en ausencia de
progresión de la enfermedad), así como al menos un año de
seguimiento para todos los pacientes.

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:

185

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

185

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

240

F.4.2.2

In the whole clinical trial

370

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)

Currently, the Sponsor does not have any plans to provide GDC-0199 or other study interventions to patients after conclusion of the study (unless required by country-specific regulations) or any earlier patient withdrawal. The Sponsor will evaluate the appropriateness of continuing to provide GDC-0199 to study patients after evaluating the primary efficacy outcome measure and safety data gathered in the study; these analyses may be conducted prior to the completion of the study.

Actualmente, el promotor no tiene planes para proporcionar GDC-0199 u otras intervenciones del estudio a los ptes tras el fin del estudio (a menos que lo requieran las normativas específicas de un país) o cualquier retirada anticipada de un pte.El promotor evaluará si es apropiado continuar dando GDC-0199 a los ptes del estudio tras
evaluar la medida ppal del resultado de eficacia y los datos de seguridad reunidos en el estudio; estos análisis pueden realizarse antes de finalizar el estudio.

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

2014-04-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-03-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-08-03

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