Clinical Trials Register

Summary
EudraCT Number:	2017-004556-27
Sponsor's Protocol Code Number:	D933IC00003
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:	2018-03-14
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

2017-004556-27

A.3

Full title of the trial

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Cisplatin-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

Ensayo clínico fase II, aleatorizado, multicéntrico, doble ciego, internacional, comparativo para determinar la eficacia y la seguridad de durvalumab en combinación con olaparib para el tratamiento en primera línea, en pacientes con cáncer urotelial irresecable en estadio IV inelegibles para tratamiento con cisplatino

A.3.1

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

A randomized, blinded clinical study comparing the combination durvalumab and olaparib to durvalumab alone for patients with advanced bladder cancer

Ensayo clínico aleatorizado, doble ciego que compara la combinación de durvalumab y olaparib frente durvalumab solo en pacientes con cáncer urotelial avanzado.

A.3.2

Name or abbreviated title of the trial where available

BAYOU

A.4.1

Sponsor's protocol code number

D933IC00003

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	Unidad de Investigación Clínica
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034900200444
B.5.6	E-mail	informacionEECC-Spain@astrazeneca.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	durvalumab
D.3.2	Product code	MEDI4736
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	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
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	50
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: 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	olaparib 100mg
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	olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	AZD2281
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: 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	olaparib 150mg
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	olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	AZD2281
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Unresectable Stage IV Urothelial Cancer

Cáncer urotelial irresecable en estadio IV

E.1.1.1

Medical condition in easily understood language

Bladder cancer or cancer of the urinary collecting system that has spread to other parts of the body or is not treatable with surgery

Cáncer de vejiga o cáncer del sistema colector urinario que se ha diseminado a otras partes del cuerpo o no se puede tratar con cirugía

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	LLT
E.1.2	Classification code	10022880
E.1.2	Term	Invasive bladder cancer stage IV
E.1.2	System Organ Class	100000004864

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 assess the efficacy of durvalumab + olaparib combination therapy compared with durvalumab + placebo in terms of PFS in the subset of patients with HRR mutation (HRRm)

Evaluar la eficacia del tratamiento combinado con durvalumab + olaparib en comparación con durvalumab + placebo en cuanto a SSP en el subgrupo de pacientes con RRHm.

E.2.2

Secondary objectives of the trial

Key secondary objective: To assess the efficacy of durvalumab + olaparib combination therapy compared with durvalumab + placebo in the subset of randomized patients with HRRm.
Endpoint: OS.

Additional secondary objectives: To assess the efficacy of durvalumab + olaparib combination therapy compared with durvalumab + placebo in the subset of randomized patients with HRRm. Endpoint: DoR, ORR, APF6 (patients Alive and Progression Free at 6 months), OS18.

To assess the PK of durvalumab and olaparib in both treatment arms

To investigate the immunogenicity of durvalumab in both treatment arms

To assess disease-related symptoms and HRQoL in patients with UC treated with durvalumab + olaparib combination therapy compared with durvalumab + placebo in the subset of randomized patients with HRRm

Objetivo secundario fundamental:
Evaluar la eficacia del tratamiento combinado con durvalumab + olaparib en comparación con durvalumab + placebo en el subgrupo de pacientes aleatorizados con RRHm
Variable principal: SG

Objetivos secundarios adicionales:
Evaluar la eficacia del tratamiento combinado con durvalumab + olaparib en comparación con durvalumab + placebo en el subgrupo de pacientes aleatorizados con RRHm
Variable principal: DR, TRO y VSP6 (pacientes vivos y libres de progresión a los 6 meses), SG18

Evaluar la FC de durvalumab y olaparib en ambos grupos de tratamiento

Investigar la inmunogenicidad de durvalumab en ambos grupos de tratamiento

Evaluar los síntomas relacionados con la enfermedad y la CVRS en pacientes con CU tratados con durvalumab + olaparib en combinación en comparación con durvalumab + placebo en el subgrupo de pacientes aleatorizados con RRHm

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of signed and dated, written ICF 3. 4
2. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease.
3. Ineligible for cisplatin-based chemotherapy defined as meeting one of the following criteria: CrCl <60 mL/min calculated by Cockcroft-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE Grade ≥2 peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2.
4. Known tumor HRR mutation status prior to randomization.
5. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2.
6. Patients with at least 1 RECIST 1.1 target lesion at baseline.
7. Ability to swallow oral medications.
8. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

1. Previsión del Consentimiento Informado fechado y firmado por escrito.
2. CU/CCT histológicamente o citológicamente documentados del urotelio (incluyendo la pelvis renal, los uréteres, la vejiga urinaria y la uretra) que también cumplen con los siguientes criterios: enfermedad Irresecable Estadio IV; No terapia sistémica previa para la enfermedad irresecable, Estadio IV.
3. Inelegibles para la quimioterapia basada en cisplatino definida cumpliendo alguno de los siguientes criterios: CrCL <60ml/min calculado por la ecuación de Cockcroft-Gault, Criterios de Terminología Comunes para Eventos Adversos (CTCEA) de pérdida auditiva audiometrica de grado ≥2 (25 dB en 2 rangos de onda consecutivas), CTCEA neuropatía periférica de Grado ≥ 2, insuficiencia cardiaca de clase III de la Asociación del Corazón de Nueva York; ECOG 2.
4. Tumor con la mutación de RRH conocida antes de la aleatorización.
5. Organización Mundial de la Salud (OMS)/estado de funcionamiento de la ECOG de 0,1, o 2.
6. Pacientes con al menos 1 lesión objetivo RECIST 1.1 al inicio del estudio.
7. Capacidad para tragar medicación oral.
8. Evidencia del estado post-menopaúsico, o prueba del embarazo urinaria o sérica negativa para las pacientes mujeres pre-menopaúsicas.

E.4

Principal exclusion criteria

1. Active or prior documented autoimmune or inflammatory disorders.
2. Other invasive malignancy within 5 years before the first dose of the IP.
3. Major surgical procedure within 28 days prior to the first dose
4. Brain metastases or spinal cord compression unless the patient’s condition is stable and off steroid for at least 14 days
5. History of active primary immunodeficiency.
6. Active infection including tuberculosis (TB)
7. History of allogenic organ transplantation.
8. Uncontrolled intercurrent illness
9. Prior exposure to a PARP inhibitor or immune-mediated therapy.
10. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
11. Current or prior use of immunosuppressive medication within 14 days before the first
dose of the IP.
12. No radiation therapy is allowed, unless it is (1) definitive radiation that had been administered at least 12 months prior; (2) palliative radiation to the brain, with associated criteria for stability or lack of symptoms; or (3) palliative radiation to painful bony lesions (this must comprise less than 30% of the bone marrow) or symptomatic pelvic soft tissue mass(es).
13. Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP.
14. Patients with a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products.
15. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.

1. Enfermedades autoinmunes o inflamatorias activas o documentadas previamente.
2. Otra neoplasia maligna invasiva dentro de los 5 años anteriores de la primera dosis del PI.
3. Procedimientos quirúrgico importante dentro de los 28 dias previos a la primera dosis.
4. Metástasis cerebral o compresión de la medula espinal al menos que la condición del paciente sea estable y fuera de esteroides al menos 14 dias.
5. Antecedentes de inmunodeficiencia primaria activa.
6. Infección activa incluyendo tuberculosis (TB).
7. Antecedentes de un trasplante de órgano alogénico.
8. Enfermedades intercurrentes no controlada.
9. Exposición previa a un inhibidor de PRAP o terapia mediada por inmunidad.
10. Cualquier quimioterapia concurrente, PI, biológica, o terapia hormonal para el tratamiento del cáncer.
11. Uso actual o previo de medicación inmunosupresora dentro de los 14 dias anteriores de la primera dosis del PI.
12. La terapia radioactiva no está permitida, a menos que (1) la radiación definitiva haya sido administrada al menos 12 meses antes; (2) radiación paliativa para el cerebro, criterios asociados con la estabilidad o ausencia de síntomas; o (3)radiación paliativa al lesiones oseas dolorosas (tiene que comprender menos del 30% de la medula ósea) o masa del tejido blando pélvico sintomático.
13. Haber recibido una vacuna viva atenuada dentro de los 30 dias previos a la primera dosis de PI.
14. Pacientes con hipersensibilidad conocida a durvalumab, olaparib, o cualquiera de los excipientes de los productos.
15. Pacientes mujeres que estén embarazadas o dando el pecho o pacientes masculinos o femeninos con potencial reproductivo que no están dispuestos a utilizar métodos anticonceptivos eficaces desde el cribado hasta 90 días después de la última dosis de durvalumab.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS)

Supervivencia sin progresión (SSP)

E.5.1.1

Timepoint(s) of evaluation of this end point

Patient level:

Assessment for treatment will be made every 4 weeks during the treatment period.

Nivel del paciente:

Se debe evaluar el tratamiento cada 4 semanas durante el período de tratamiento.

E.5.2

Secondary end point(s)

Main secondary end point is:
OS (overall survival)

Other secondary efficacy endpoints include:
Duration of response (DoR)
Objective Response Rate (ORR)
Progression-free at 6 months (APF6)
Patients alive at 18 months (OS18)
Concentration of durvalumab and olaparib
Presence of anti-drug antibodies (ADA) for durvalumab
Patient reported outcome (PRO)including Global health status/QoL, assessed through questionnaire - EORTC QLQ-C30

Variable secundaria:
SG (Supervivencia global)

Otras variables secundarias incluidas:
Duración de la respuesta (DR)
Tasa de repuesta objetiva (TRO)
Sin progresión a los 6 meses (VSP6)
Pacientes vivos a los 18 meses (SG18)
Concentración de durvalumab y olaparib
Presencia de anticuerpos contra el fármaco (ACF) dirigidos contra durvalumab
Resultados comunicados por los pacientes(RCP) incluidos estado general de salud/calidad de vida, evaluados a través de un cuestionario QLQ-LC30 de la EORTC

E.5.2.1

Timepoint(s) of evaluation of this end point

OS (overall survival) and OS18
Assessment every month until 4 months post-treatment discontinuation; every 2 months thereafter.

Other secondary endpoints
DoR, ORR, and APF6 will be assessed every 8 weeks (±1 week) for the first 48 weeks; then every 12 weeks (±1 week) thereafter until progression.
Concentration of durvalumab and olaparib will be assessed three times, in Cycle 1, 2 and 4. Additional assessments at Day 30 post last dose for olaparib, 3 months post last dose for durvalumab.
ADA for durvalumab will be assessed three times, in Cycle 1, 2 and 4, and 3 and 6 months post last dose of durvalumab.

PRO:Global health status assessment on day of first dose and every 4 weeks until 3 months post treatment discontinuation.

SG (Supervivencia global) y SG18
Evaluación cada mes durante 4 meses después de interrumpir el tratamiento; cada 2 meses después.

Otras variables secundarias
DR, TRO y VSP6 se evaluará cada 8 semanas (± 1 semana) durante las primeras 48 semanas; después cada 12 semanas (± 1 semana) hasta progresión.
Se evaluará la concentración de durvalumab y olaparib tres veces, en los ciclos 1,2 y 4. Evaluaciones adicionales en el Día 30 después de la última dosis de olaparib, 3 meses después de la última dosis de durvalumab.
Se evaluará ACF para durvalumab 3 veces, en los ciclos 1,2 y 4 y a los 3 y 6 meses después de la última dosis de durvalumab.

RCP: estado general de salud el día de la primera dosis y cada 4 meses hasta 3 meses después de la interrupción del tratamiento.

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

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Spain

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 the last expected visit/contact of the last patient undergoing the study.

El fin del estudio se define como la ultima visita/contacto esperado del último paciente que participó en el estudio.

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

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:

192

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

256

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 who are receiving treatment at the time of the final DCO may continue receiving durvalumab or durvalumab and olaparib if the Investigator judges that they are gaining clinical benefit.

Pacientes que están recibiendo tratamiento en el momento final DCO que debe continuar recibiendo durvalumab o durvalumab y olaparib si el investigador considera que están teniendo un beneficio clínico.

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

2018-04-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-10-15

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IMP with orphan designation in the indication
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