Clinical Trials Register

Summary
EudraCT Number:	2017-004557-17
Sponsor's Protocol Code Number:	CO-338-087
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-14
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-004557-17

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

ATHENA (Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo in pazienti con cancro dell’ovaio per valutare rucaparib e nivolumab come trattamento di mantenimento dopo risposta alla chemioterapia di prima linea a base di platino)

A.3.1

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

Blinded, Placebo-Controlled Study to investigate the safety and efficacy of Rucaparib and Nivolumab as Maintenance Treatment in Patients with Ovarian Cancer who have responded to a Platinum-Based Chemotherapy

Studio cieco, controllato con placebo per studiare la sicurezza e l'efficacia di Rucaparib e Nivolumab come terapia di mantenimento in pazienti con tumore ovarico che hanno risposto a una terapia a base di platino

A.3.2

Name or abbreviated title of the trial where available

ATHENA

A.4.1

Sponsor's protocol code number

CO-338-087

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03522246

A.5.4

Other Identifiers

Name:

ENGOT

Number:

ENGOT-ov45/NCRI/ATHENA

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	CLOVIS ONCOLOGY, INC
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Clovis oncology, INC.
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	Clovis Oncology UK Ltd
B.5.2	Functional name of contact point	Chief Medical Officer
B.5.3	Address:
B.5.3.1	Street Address	Granta Centre, Granta Park
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	CB21 6GP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441223645500
B.5.5	Fax number	+441223281382
B.5.6	E-mail	info@clovisoncology.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.2.1.1.1	Trade name	Rubraca 200 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Clovis Oncology UK 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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1049
D.3 Description of the IMP
D.3.1	Product name	Rucaparib
D.3.2	Product code	CO-338
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	Rucaparib
D.3.9.1	CAS number	283173-50-2
D.3.9.2	Current sponsor code	CO-338
D.3.9.4	EV Substance Code	SUB74859
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	200
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.2.1.1.1	Trade name	Rubraca 250 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Clovis Oncology UK 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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1049
D.3 Description of the IMP
D.3.1	Product name	Rucaparib
D.3.2	Product code	CO-338
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	Rucaparib
D.3.9.1	CAS number	283173-50-2
D.3.9.2	Current sponsor code	CO-338
D.3.9.4	EV Substance Code	SUB74859
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	250
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.2.1.1.1	Trade name	Rubraca 300 mg film-coated tablets
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/12/1049
D.3 Description of the IMP
D.3.1	Product name	Rucaparib
D.3.2	Product code	CO-338
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	Rucaparib
D.3.9.1	CAS number	283173-50-2
D.3.9.2	Current sponsor code	CO-338
D.3.9.4	EV Substance Code	SUB74859
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	300
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	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	Nivolumab
D.3.2	Product code	BMS 936558-01
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	Nivolumab
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558
D.3.9.3	Other descriptive name	ONO-4538
D.3.9.4	EV Substance Code	SUB32944
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.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
D.8 Placebo: 3
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

advanced (FIGO stage III-IV), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (who responded to front-line platinum-based chemotherapy)

Carcinoma epiteliale dell’ovaio, peritoneale primario o delle tube di Falloppio di alto grado (stadio FIGO III-IV), neodiagnosticato (che ha risposto alla chemioterapia di prima linea a base di platino)

E.1.1.1

Medical condition in easily understood language

Ovarian Cancer Patients (who responded to previous platinum-based chemotherapy)

Pazienti con tumore ovarico (che hanno risposto alla precedente chemioterapia a base di 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	PT
E.1.2	Classification code	10061328
E.1.2	Term	Ovarian epithelial cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10016180
E.1.2	Term	Fallopian tube cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10061269
E.1.2	Term	Malignant peritoneal neoplasm
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate PFS by Response Evaluation Criteria in Solid Tumors (RECIST), as assessed by the investigator (invPFS), in HRD and intent-to-treat (ITT) sub/populations, using the following separate comparisons:
- Monotherapy: Arm B (oral rucaparib+IV placebo) versus Arm D (placebo [oral and IV])
- Combination: Arm A (oral rucaparib+ intravenous [IV] nivolumab) versus Arm B (oral rucaparib+IV placebo)

Valutare la PFS mediante i criteri di valutazione della risposta nei tumori solidi (RECIST), come valutato dallo sperimentatore (invPFS), in sottogruppi HRD e intent-to-treat (ITT), utilizzando i seguenti confronti separati:
- Monoterapia: Braccio B (rucaparib orale + IV placebo) rispetto al braccio D (placebo [orale e IV])
- Combinazione: Braccio A (rucaparib orale + IV nivolumab) rispetto al braccio B (orale rucaparib + IV placebo)

E.2.2

Secondary objectives of the trial

• To evaluate PFS by RECIST, as assessed by the blinded independent central review (BICR; bicrPFS), in molecularly-defined HRD subgroups
• To evaluate survival benefit
• To evaluate the objective response rate (ORR) and duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline
• To evaluate safety

• Valutare la PFS mediante RECIST, come valutato da una revisione centrale indipendente in cieco (BICR; bicrPFS), in sottogruppi HRD molecolarmente definiti
• Valutare il beneficio di sopravvivenza
• Valutare il tasso di risposta obiettivo (ORR) e la durata della risposta (DOR), come valutato dallo sperimentatore, in pazienti con malattia misurabile al baseline
• Valutare la sicurezza

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
• Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
• Sufficient tumor tissue for planned analysis
• ECOG performance status of 0 or 1

- Avere un carcinoma epiteliale dell’ovaio, delle tube di Falloppio o peritoneale primario di alto grado, neodiagnosticato, confermato istologicamente e in stadio avanzato (stadio III-IV della International Federation of Gynecology and Obstetrics [FIGO]).
- Essere state sottoposte a chirurgia citoriduttiva, che abbia incluso almeno una salpingo-ovariectomia bilaterale e una omentectomia parziale, prima della chemioterapia (chirurgia primaria) o dopo la chemioterapia neoadiuvante (interval debulking o “chirurgia di intervallo”).
- Aver completato la chemioterapia a base di platino di prima linea e la chirurgia e aver presentato una risposta definibile, secondo il giudizio dello sperimentatore
- Sufficiente tessuto tumorale per analisi pianificate
- Stato delle prestazioni ECOG pari a 0 o 1

E.4

Principal exclusion criteria

• Pure sarcomas or borderline tumors or mucinous tumors
• Active second malignancy
• Known central nervous system brain metastases
• Any prior treatment for ovarian cancer, other than the first-line platinum regimen
• Evidence of interstitial lung disease, active pneumonitis, myocarditis or a history of myocarditis
• Active, known or suspected autoimmune disease (e.g. autoimmune hepatitis)
• Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications

- Tumori non epiteliali (sarcomi puri) o tumori ovarici con basso potenziale maligno (tumori borderline) o tumori mucinosi
- Seconda neoplasia maligna attiva
- Metastasi cerebrali note nel sistema nervoso centrale.
- Qualsiasi precedente trattamento per il cancro ovarico diverso dal regime di prima linea a base di platino
- Evidenza di malattia polmonare interstiziale o di polmonite attiva, miocardite o storia di miocardite.
- Pazienti con malattia autoimmune attiva, nota o sospetta (ad esempio epatite autoimmune)
- Pazienti con una patologia che richieda il trattamento sistemico con corticosteroidi (dose prednisone-equivalente > 10 mg/die) o altri medicinali immunosoppressori

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint for the study is investigator-determined progression-free survival (PFS) by RECIST v1.1. Investigator-determined PFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first.

L'endpoint primario di efficacia per lo studio è la sopravvivenza libera da progressione mediante (PFS) da RECIST v1.1 determinata dallo sperimentatore. La PFS determinata dallo sperimentatore è definita come il tempo che intercorre tra la randomizzazione e la progressione della malattia, secondo i criteri di RECIST v1., o la morte dovuta a qualsiasi causa, a seconda di quale si verifica prima.

E.5.1.1

Timepoint(s) of evaluation of this end point

Tumor assessment measurements will be performed at screening, at the end of every 12 weeks of treatment (up to 7 days prior permitted) relative to Cycle 2 Day 1 for the first 3 years and then every 24 weeks thereafter until objective radiological disease progression, and as clinically indicated.

Le misurazioni della valutazione del tumore saranno eseguite allo screening, al termine di ogni 12 settimane di trattamento (fino a 7 giorni prima consentite) relativo al ciclo 2 giorno 1 per i primi 3 anni e successivamente ogni 24 settimane successivamente fino alla progressione obiettiva radiologica della malattia, e come clinicamente indicato.

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints: Progression-free survival (PFS) as assessed by blinded independent central review (BICR) by RECIST is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by BICR, or death due to any cause, whichever occurs first. Only tumor scans prior to start of any subsequent anti-cancer treatment are included. Overall survival is defined as the time from randomization to death due to any cause. Analyses of objective response rate (ORR) will be performed in the subgroup of patients with measurable disease at baseline and will be summarized with frequencies and percentages. Duration of response is defined as the interval from the first documentation of objective response (RECIST v1.1) to the earlier of the first documentation of disease progression (per RECIST v1.1) or death from any cause. Safety Analysis: Adverse events, clinical laboratory results, vital signs, ECOG performance status, body weight, and concomitant medications/procedures

Endpoint secondari di efficacia: la sopravvivenza libera da progressione (PFS) valutata mediante revisione centrale indipendente in cieco (BICR) da RECIST è definita come il tempo dalla randomizzazione alla progressione della malattia, secondo i criteri RECIST v1.1 come valutato dal BICR, o morte dovuta a qualsiasi causa, a seconda di quale si verifica prima. Sono incluse solo le scansioni del tumore prima dell'inizio di qualsiasi trattamento antitumorale successivo. La sopravvivenza globale è definita come il tempo dalla randomizzazione alla morte a causa di qualsiasi causa. Le analisi del tasso di risposta obiettiva (ORR) saranno eseguite nel sottogruppo di pazienti con malattia misurabile al basale e saranno riassunte con frequenze e percentuali. La durata della risposta è definita come l'intervallo dalla prima risposta obiettiva documentata (RECIST v1.1) alla prima della prima documentazione della progressione della malattia (per RECIST v1.1) o morte per qualsiasi causa. Analisi di sicurezza: eventi avversi, risultati di laboratorio clinici, segni vitali, stato delle prestazioni ECOG, peso corporeo e farmaci / procedure concomitanti

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: as for primary endpoint; (Overall survival is monitored continuously) Safety: at every study visit

Efficacia: come per l'endpoint primario; (La sopravvivenza complessiva è monitorata continuamente) Sicurezza: ad ogni visita di studio

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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)

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

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

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

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Israel

Japan

Korea, Republic of

New Zealand

Russian Federation

Singapore

Taiwan

Turkey

United States

Belgium

Denmark

Finland

Germany

Greece

Ireland

Italy

Poland

Romania

Spain

Sweden

United Kingdom

Czechia

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:

650

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

350

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

350

F.4.2.2

In the whole clinical trial

1000

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)

Standard care

Cure standard

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	ENGOT-Cancer Research UK & UCL Cancer trials Centre
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

2018-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-19

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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