Clinical Trials Register

Summary
EudraCT Number:	2017-000265-67
Sponsor's Protocol Code Number:	APR-486
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:	2017-05-29
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

2017-000265-67

A.3

Full title of the trial

PiSARRO-R: p53 Suppressor Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Phase II Study of Systemic Pegylated Liposomal Doxorubicin Chemotherapy With APR-246

PiSARRO-R: Activación de la proteína de supresión tumoral p53 en carcinoma seroso de alto grado resistente a platino en ovario, ensayo clínico de fase II de quimioterapia sistémica de doxorrubicina liposomal pegilada con APR-246

A.3.1

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

A study of systemic carboplatin/PLD combination chemotherapy with or without APR-246 in patients with Platinum-resistant high grade serous ovarian
cancer

Estudio sobre el tratamiento de quimioterapia sistémica de doxorrubicina liposomal pegilada con APR-246 en paciente con carcinoma seroso de alto grado resistente a platino en ovario

A.4.1

Sponsor's protocol code number

APR-486

A.5.4

Other Identifiers

Name:

IND

Number:

124841

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	Aprea Therapeutics 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	Aprea Therapeutics 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	Theradex (Europe) Ltd
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	2nd Floor, The Pinnacle, Station Way
B.5.3.2	Town/ city	Crawley
B.5.3.3	Post code	RH10 1JH
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441293510319
B.5.5	Fax number	+441293510322
B.5.6	E-mail	regulatory@theradex.co.uk

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/3/14/1386
D.3 Description of the IMP
D.3.1	Product name	APR-246
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	APR-246
D.3.9.3	Other descriptive name	APR-246
D.3.9.4	EV Substance Code	SUB31235
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	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.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	doxorubicin hydrochloride 2mg/ml solution for infusion
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Doxorubicin hydrochloride (pegylated liposomal)
D.3.4	Pharmaceutical form	Concentrate and solvent 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	Doxorubicin hydrochloride
D.3.9.3	Other descriptive name	DOXORUBICIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB01827MIG
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
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

Platinum-resistant high grade serous ovarian carcinoma

Carcinoma de ovario seroso de alto grado resistente a platino

E.1.1.1

Medical condition in easily understood language

Platinum-resistant high grade serous ovarian carcinoma

Carcinoma de ovario seroso de alto grado resistente a platino

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	10033131
E.1.2	Term	Ovarian carcinoma
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 preliminary efficacy of APR-246 with PLD chemotherapy in patients with platinum-resistant HGSOC with mutated TP53

Evaluar la eficacia preliminar de APR-246 con quimioterapia de PLD en pacientes con cáncer de ovario seroso de alto grado con mutación del gen TP53 resistente al platino

E.2.2

Secondary objectives of the trial

• To evaluate the pharmacokinetics (PK) of methylene quinuclidinone (if possible) and APR-246 when administered with PLD chemotherapy
• To evaluate cardiac safety of APR-246 when administered with PLD chemotherapy
• To assess the safety and tolerability of APR-246 with PLD chemotherapy in patients with platinum-resistant HGSOC with mutated TP53
• To assess:
o Duration of response (complete or partial response)
o Progression-free survival (PFS) by assessment of cancer antigen 125 (CA-125)
o PFS by RECIST 1.1
• To evaluate potential biomarkers and tumor activity based on CA-125
• To assess the biological activity in tumor and surrogate tissues

- Evaluar la farmacocinética (FC) de metileno quinuclidinona (si es posible) y APR-246 cuando se administran con quimioterapia de PLD.
- Evaluar la seguridad cardiaca de APR-246 cuando se administra con quimioterapia de PLD.
- Evaluar la seguridad y la tolerabilidad de APR-246 con quimioterapia de PLD en pacientes con cáncer de ovario seroso de alto grado con mutación del gen TP53 resistente al platino.
- Evaluar:
o la duración de la respuesta (respuesta completa o parcial);
o la supervivencia sin progresión (SSP) mediante evaluación del antígeno del cáncer 125 (CA-125);
o SSP según los criterios RECIST 1.1.
- Evaluar los posibles biomarcadores y la actividad tumoral según CA-125.
- Evaluar la actividad biológica en tejidos tumorales y tejidos sustitutos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Archived sections from the original formalin fixed paraffin embedded sample reviewed by a gynecological pathologist confirming HGSOC, high grade serous peritoneal cancer or primary fallopian tube cancer and positive immunohistochemistry staining for p53 assessed according to the local methodology (as detailed in the laboratory manual). Cases that do not show p53 staining will not be included.
2. Disease progression between 4 weeks and 6 months after the last platinum-based treatment was administered.
3. At least a single (RECIST 1.1) measurable lesion.
4. Adequate organ function prior to registration:
a) Bone marrow reserve
• Absolute neutrophil count (ANC) ≥ 1.5 x109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin ≥ 9 g/dL
b) Hepatic
• Total bilirubin level < 1.5 x ULN without hepatic metastasis, and < 4 x ULN with hepatic metastasis
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN without hepatic metastasis, and < 4 x ULN with hepatic metastasis
c) Renal
• Calculated creatinine clearance > 30 mL/min calculated per local practice
d) Electrolytes
• Potassium within institutional normal ranges.
5. Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the Principal Investigator.
6. If of childbearing potential, negative pretreatment serum pregnancy test.
7. If of childbearing potential, willing to use an effective form of contraception (see below) during chemotherapy treatment and for at least 6 months thereafter. Such methods include the following (if using hormonal contraception, this method must be supplemented with a barrier method, preferably male condom):
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
o oral
o intravaginal
o transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation:
o oral
o injectable
o implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomized partner
• true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix I).
9. ≥ 18 years of age.
10. Signed informed consent.

1. Un ginecopatólogo revisará los cortes de la muestra original fijados con formol y embebidos en parafina para confirmar el cáncer de ovario seroso de alto grado, el cáncer peritoneal seroso de alto grado o el cáncer primario de las trompas de Falopio y tinción positiva para p53 mediante inmunohistoquímica evaluada según la metodología local (tal como se detalla en el manual de laboratorio). No se incluirán los casos que no expresen tinción positiva para p53.
2. Progresión de la enfermedad entre 4 semanas y 6 meses después de la administración del último tratamiento a base de platino.
3. Al menos una lesión cuantificable (según los criterios RECIST 1.1).
4. Función orgánica adecuada antes de la inscripción:
a) Reserva de médula ósea:
 recuento absoluto de neutrófilos (RAN) ≥1,5 × 109/l;
 plaquetas ≥100 × 109/l;
 hemoglobina ≥9 g/dl.
b) Función hepática:
 bilirrubina total <1,5 × LSN (límite superior de normalidad) sin metástasis hepática y <4 × LSN con metástasis hepática;
 alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) <2,5 × LSN sin metástasis hepática <4 × LSN con metástasis hepática.
c) Función renal:
 aclaramiento de creatinina calculado >30 ml/min, calculado según la práctica local.
d) Electrolitos:
 Potasio dentro de los intervalos normales institucionales.
5. Toda toxicidad asociada a tratamientos antineoplásicos anteriores (a excepción de la alopecia) debe haberse recuperado hasta grado 1 (de acuerdo con la versión 4.0 de los CTCAE [Criterios terminológicos comunes para acontecimientos adversos del Instituto Nacional del Cáncer]). El investigador principal puede considerar caso por caso la neuropatía periférica de grado 2, crónica y estable que sea secundaria a la neurotoxicidad de los tratamientos anteriores.
6. En el caso de las mujeres potencialmente fértiles, resultado negativo en una prueba de embarazo en suero antes del tratamiento.
7. Las mujeres potencialmente fértiles deberán estar dispuestas a utilizar un método anticonceptivo eficaz (véase a continuación) mientras dure la quimioterapia y, al menos, durante seis meses más después de terminarla. Estos métodos incluyen los siguientes (si se utilizan anticonceptivos hormonales, este método se debe complementar con un método de barrera, preferiblemente un preservativo masculino):
 Anticonceptivos hormonales combinados (contienen estrógenos y progestágenos) asociados con la inhibición de la ovulación:
o orales;
o intravaginales;
o transdérmicos.
 Anticonceptivos hormonales que contienen solamente progestágenos asociados con la inhibición de la ovulación:
o orales;
o inyectables;
o implantables.
 Dispositivo intrauterino (DIU).
 Sistema intrauterino de liberación de hormonas (SIU).
 Oclusión tubárica bilateral.
 Vasectomía de la pareja.
 Abstinencia sexual completa cuando corresponde con el estilo de vida preferido y habitual de la mujer. La abstinencia periódica (por ejemplo, métodos de calendario, de ovulación, sintotérmico o posovulación), la declaración de abstinencia durante todo el ensayo y el coito interrumpido no son métodos anticonceptivos aceptables.
8. Grado de actividad ECOG (Eastern Cooperative Oncology Group) de 0 a 2 (apéndice I).
9. ≥18 años.
10. Consentimiento informado firmado.

E.4

Principal exclusion criteria

1. Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2.
2. Confirmed cardiac history of any of the following:
a) A myocardial infarct within 6 months prior to registration,
b) New York Heart Association Class II or worse heart failure (Appendix II)
c) A history of familial long QT syndrome
d) Clinically significant pericardial disease
e) Electrocardiographic evidence of acute ischemia
f) Atrial or ventricular arrhythmias not controlled by medications
g) QTc ≥ 480 msec calculated from a single electrocardiogram (ECG) reading or a mean of three ECG readings using Fridericia’s correction (QTcF = QT/RR0.33)
h) Bradycardia (< 40 bpm)
i) Left ventricular ejection fraction (LVEF) < the institution lower limit of normal as assessed by echocardiogram.
3. Major abdominal surgery or peritonitis within 6 weeks prior to study treatment.
4. Unresolved bowel obstruction, subocclusive disease or the presence of brain metastases.
5. Hypersensitivity to PLD or to any of the excipients.
6. Unable to undergo imaging by either computed tomography (CT) scan or magnetic resonance imaging (MRI).
7. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications.
8. Breast feeding.
9. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
10. Known HIV positive status, active hepatitis B or C status.
11. Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed.

1. Exposición previa a dosis acumuladas >400 mg/m2 de doxorrubicina o >720 mg/m2 de epirrubicina.
2. Antecedentes confirmados de cualquiera de las siguientes afecciones cardíacas:
a) Un infarto de miocardio en los seis meses previos a la inscripción.
b) Insuficiencia cardiaca de clase II o más grave según la clasificación de New York Heart Association (apéndice II).
c) Antecedentes familiares de síndrome de QT largo.
d) Enfermedad pericárdica clínicamente significativa.
e) Indicios electrocardiográficos de isquemia aguda.
f) Arritmias auriculares o ventriculares no controladas con medicación.
g) QTc ≥480 ms establecido a partir de una única lectura de ECG o de la media de tres lecturas de ECG usando la corrección de Fridericia (QTcF = QT/RR 0,33).
h) Bradicardia (<40 lpm).
i) Fracción de eyección ventricular izquierda (FEVI) < el límite inferior de la normalidad del centro, establecida mediante una ecocardiografía.
3. Cirugía abdominal mayor o peritonitis durante las seis semanas previas al tratamiento del estudio.
4. Oclusión intestinal sin resolver, lesión suboclusiva o presencia de metástasis cerebrales.
5. Hipersensibilidad a PLD o a algunos de los excipientes.
6. Incapacidad para someterse a pruebas de imagen mediante tomografía computarizada (TC) o resonancia magnética (RM).
7. Indicios de otras afecciones médicas (como enfermedad psiquiátrica, enfermedades infecciosas, afecciones neurológicas, resultados de la exploración física o analíticas) que puedan interferir en el tratamiento previsto, afectar a la adherencia al tratamiento por parte de la paciente o poner en peligro a la paciente debido a las complicaciones relacionadas con el tratamiento.
8. Lactancia.
9. Neoplasia maligna concurrente que requiera tratamiento (a excepción del carcinoma no invasivo o del carcinoma localizado).
10. Infección por el VIH o hepatitis B o C activas.
11. Administración simultánea (o en las cuatro semanas previas a la inscripción) de quimioterapia, inmunoterapia, radioterapia o un tratamiento complementario que se considere en investigación (es decir, utilizado para indicaciones no aprobadas y en el contexto de una investigación clínica). Están permitidos los tratamientos complementarios. Está permitida la radioterapia paliativa limitada para reducir el dolor.

E.5 End points

E.5.1

Primary end point(s)

• Overall response rate according to RECIST 1.1

Tasa de respuesta global según los criterios RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to protocol

Ver protocolo

E.5.2

Secondary end point(s)

• PFS rate, defined as the time from registration to the time of disease progression or relapse (according to RECIST 1.1 only) or death, or the date of last tumor assessment without any such event (censored observation)
• PK profiles of methylene quinuclidinone (if possible) and APR-246 and concentration of PLD in plasma
• Cardiac profile of APR-246 and concentration of PLD
• The safety profile (adverse events [AEs], laboratory assessments, physical findings and biomarkers) of APR 246 and PLD chemotherapy
• Duration of response (complete or partial response)
• Progression-free survival (PFS) by assessment of CA-125
• Evaluation of potential biomarkers
• Biological activity in tumor and surrogate tissues

- Tasa de supervivencia sin progresión, definida como el tiempo desde la inscripción hasta la progresión de la enfermedad o la recaída (exclusivamente según los criterios RECIST 1.1) o hasta la muerte, o hasta la fecha de la última evaluación tumoral sin dichos acontecimientos (observación censurada).
- Perfiles FC de metileno quinuclidinona (si es posible) y APR-246 y concentración plasmática de PLD.
- Perfil cardiaco de APR-246 y concentración de PLD.
- Perfil de seguridad (acontecimientos adversos [AA], análisis de laboratorio, hallazgos físicos y biomarcadores) de APR-246 y de la quimioterapia de PLD.
- Duración de la respuesta (respuesta completa o parcial).
Otros (ver sinopsis)v

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to protocol

Ver protocolo

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

E.6.12

Pharmacoeconomic

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

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:

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

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

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)

Survival after progression will be monitored every 6 months until death. This can be done remotely (e.g., via telephone, via general practitioner or via review of medical records).

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	EUTROC
G.4.3.4	Network Country	United Kingdom

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-16

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

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Select Trial Status:	Select Trial Phase:
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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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