Clinical Trials Register

Summary
EudraCT Number:	2017-003699-30
Sponsor's Protocol Code Number:	BGB-A317-302
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:	2018-02-16
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-003699-30

A.3

Full title of the trial

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the anti-PD-1 Antibody BGB-A317 versus Chemotherapy as Second Line Treatment in Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

Studio randomizzato, controllato, in aperto, globale di fase 3 per confrontare l’efficacia dell’anticorpo anti-PD-1 BGB-A317 rispetto alla chemioterapia come trattamento di seconda linea in pazienti con carcinoma esofageo a cellule squamose non operabile/metastatico avanzato

A.3.1

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

Phase 3 study of Antibody BGB-A317 versus Chemotherapy in Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

Studio di fase 3 dell’anticorpo anti-PD-1 BGB-A317 rispetto alla chemioterapia in pazienti con carcinoma esofageo a cellule squamose non operabile/metastatico avanzato

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

BGB-A317-302

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	BeiGene, Ltd.c/o BeiGene USA, 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	BeiGene, Ltd.
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	BeiGene, Ltd.
B.5.2	Functional name of contact point	BeiGene Clinical Support
B.5.3	Address:
B.5.3.1	Street Address	USA
B.5.3.2	Town/ city	USA
B.5.3.3	Post code	USA
B.5.3.4	Country	United States
B.5.6	E-mail	BeigeneClinicalSupportUS@beigene.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	BGB-A317
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	BGB-A317
D.3.9.1	CAS number	1858168-59-8
D.3.9.2	Current sponsor code	BGB-A317
D.3.9.3	Other descriptive name	BGB-A317
D.3.9.4	EV Substance Code	SUB189550
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	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	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	Paclitaxel 6mg/ml Concentrate For Solution For Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Actavis Group PTC ehf.
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	Paclitaxel 6mg/ml Concentrate For Solution For Infusion
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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	30
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	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	TAXOTERE 20 mg/1 ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma S.A.
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	TAXOTERE
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.3.9.3	Other descriptive name	DOCETAXEL TRIHYDRATE
D.3.9.4	EV Substance Code	SUB25446
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	20
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	CAMPTO 20 mg/ml, concentrate for solution for infusion.
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	CAMPTO
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.3.9.3	Other descriptive name	IRINOTECAN HYDROCHLORIDE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB45873
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.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

Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

Carcinoma esofageo a cellule squamose non operabile/metastatico avanzato (ESCC)

E.1.1.1

Medical condition in easily understood language

Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

Carcinoma esofageo a cellule squamose non operabile/metastatico avanzato (ESCC)

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	10055476
E.1.2	Term	Esophageal squamous cell 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 compare the overall survival (OS) following treatment with BGB-A317 vs. investigator chosen chemotherapy (ICC) when given as second line treatment in patients with advanced unresectable/metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Confrontare la sopravvivenza complessiva (OS) a seguito del trattamento con BGBA317 rispetto alla chemioterapia selezionata dallo sperimentatore (ICC) quando somministrati come trattamento di seconda linea per pazienti affetti da carcinoma squamocellulare esofageo (ESCC) avanzato non resecabile/metastatico.

E.2.2

Secondary objectives of the trial

•The following secondary endpoints will be compared between BGB-A317 and ICC as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria:
o Objective response rate (ORR)
o Progression-free survival (PFS)
o Duration of response (DOR)
• To compare patient reported outcomes of health-related quality of life (HRQoL) between the BGB-A317 and the chemotherapy treatments
• To compare the safety and tolerability between BGB-A317 and the chemotherapy treatments

• Sulla base del giudizio dello sperimentatore e secondo i criteri di valutazione della risposta nei tumori solidi (RECIST), v1.1, verrà eseguita la comparazione tra BGB-A317 e ICC per i seguenti endpoint secondari:
o Tasso di risposta obiettiva (ORR)
o Sopravvivenza libera da progressione (PFS)
o Durata della risposta (DR)
• Confrontare gli esiti riferiti dal paziente relativi alla qualità della vita correlata alla salute (HRQoL) ottenuti con BGB-A317 e i trattamenti chemioterapici
• Confrontare la sicurezza e la tollerabilità di BGB-A317 e del trattamento chemioterapico

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Safety Run-in Substudy Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-1 Monoclonal Antibody BGB A317 in Japanese Patients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
Protocol Identifier: BGB-A317-302 Substudy
Primary Study Objectives:
• To assess the safety and tolerability of BGB-A317 in Japanese patients with advanced unresectable esophageal squamous cell carcinoma (ESCC)
• To confirm the pivotal Phase 3 dose of BGB-A317 in Japanese patients
• To characterize the pharmacokinetics of BGB-A317 in Japanese patients
Secondary Study Objectives:
• To assess the preliminary antitumor activity of BGB-A317
• To assess host immunogenicity to BGB-A317

Sottostudio di run-in di sicurezza volto ad esaminare la sicurezza, la tollerabilità, la farmacocinetica e l’attività antitumorale iniziale dell’anticorpo monoclonale anti PD-1 BGB-A317 in pazienti giapponesi affetti da carcinoma squamocellulare esofageo (ESCC) avanzato non resecabile/metastatico. Identificatore del protocollo: Sottostudio BGBA317-
302.
Obiettivi primari dello studio:
• Valutare la sicurezza e la tollerabilità di BGB-A317 in pazienti giapponesi con carcinoma squamocellulare esofageo (ESCC) avanzato non resecabile
• Confermare la dose di BGB-A317 per la fase 3 in pazienti giapponesi
• Caratterizzare la farmacocinetica di BGB-A317 in pazienti giapponesi

Obiettivi secondari dello studio:
• Valutare l’attività antitumorale iniziale di BGB-A317
• Valutare l’immunogenicità di BGB-A317 nell’ospite

E.3

Principal inclusion criteria

1. Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
3. At least one measurable/evaluable lesion by RECIST v1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
5. Adequate End organ function

1. Diagnosi di carcinoma squamocellulare esofageo (ESCC) confermata all’esame anatomo-patologico (istologico o citologico)
2. Progressione del tumore durante o dopo il trattamento di prima linea per ESCC avanzato non resecabile/metastatico
3. Almeno una lesione misurabile/valutabile secondo i criteri RECIST, v 1.1
4. Stato di validità secondo il Gruppo cooperativo orientale di oncologia (ECOG) pari a 0 o 1 prima della randomizzazione
5. Funzionalità organica adeguata

E.4

Principal exclusion criteria

1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
3. Apparent tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
5. Received prior therapies targeting PD-1 or PD-L1
6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
7. Active brain or leptomeningeal metastasis.
8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
10. Known history of Human Immunodeficiency Virus (HIV)
11. Has cardiovascular risk factors
12. Pregnant or breastfeeding woman.

1. Ricezione di 2 o più precedenti trattamenti sistemici per ESCC avanzato/metastatico non resecabile
2. Anamnesi di perforazione e/o fistola gastrointestinale o fistola aortoesofagea nei 6 mesi precedenti la randomizzazione
3. Evidente invasione tumorale degli organi adiacenti alla sede della malattia esofagea (ad es. l’aorta o le vie respiratorie) valutati dallo sperimentatore a maggior rischio di fistolizzazione durante il trattamento in studio
4. Versamento pleurico, versamento pericardico o ascite non controllabili che devono essere drenati con frequenza
5. Ricezione di precedenti terapie mirate alla proteina di morte cellulare programmata (PD-1) o al ligando 1 della proteina di morte programmata (PD-L1)
6. Pregressa malignità attiva nei 2 anni precedenti (le eccezioni includono il tumore in esame nella presente sperimentazione e le neoplasie recidivanti a livello locale sottoposte a trattamento curativo, quali i tumori cutanei basocellulari o squamocellulari
resecati, le neoplasie superficiali della vescica oppure i carcinomi prostatici, cervicali o mammari in situ)
7. Metastasi encefaliche o leptomeningee attive
8. Presenza di malattia autoimmune attiva o anamnesi di patologie autoimmuni ad alto rischio di recidiva
9. Anamnesi o eventuali evidenze di interstiziopatia polmonare, polmonite non infettiva, fibrosi polmonare, diagnosticate sulla base dei risultati degli esami clinici o di diagnostica per immagini, oppure di patologie sistemiche non controllate, tra cui diabete, ipertensione, pneumopatie acute, ecc.
10. Anamnesi di infezione da virus dell’immunodeficienza umana (HIV)
11. Presenza di fattori di rischio cardiovascolare
12. Gravidanza o allattamento, per soggetti di sesso femminile.

E.5 End points

E.5.1

Primary end point(s)

• OS - defined as the time from the date of randomization until the date of death due to any cause

• OS: è definita come intervallo di tempo trascorso dalla data della randomizzazione alla data del decesso per qualsiasi causa

E.5.1.1

Timepoint(s) of evaluation of this end point

The final analysis of OS will occur at approximately 3 years

L’analisi finale dell’OS verrà condotta dopo circa 3 anni

E.5.2

Secondary end point(s)

• ORR - defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by the Investigators per RECIST v1.1
• PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the Investigators per RECIST v1.1 or death, whichever occurs first
• DOR- defined as the time from the first determination of an objective response until the first documentation of progression assessed by the Investigators per RECIST v1.1 or death, whichever comes first
• HRQoL assessment
• The incidence and severity of adverse events

• ORR: è definito come percentuale di pazienti che hanno presentato una risposta completa (RC) o una risposta parziale (RP), valutata dagli sperimentatori secondo i criteri RECIST v1.1
• PFS: è definita come intervallo di tempo trascorso dalla data della randomizzazione alla data della prima documentazione di progressione della malattia, valutata dagli sperimentatori secondo i criteri RECIST v1.1, o al decesso, a seconda di quale evento si verifichi per primo
• DR: è definita come intervallo di tempo trascorso dalla prima determinazione di una risposta obiettiva fino alla prima documentazione di progressione, valutata dagli sperimentatori secondo i criteri RECIST v1.1, o al decesso, a seconda di quale evento si verifichi per primo
• Valutazione della HRQoL
• Incidenza e gravità degli eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

ORR as assessed by investigator
PFS as assessed by investigator
DOR as assessed by investigator
HRQoL as assessed by European EORTC QLQ-C30 index, the European esophageal cancer specific module OES18, and the EQ-5D-5L.
Incidence and severity of adverse events according to NCI-CTCAE v4.0

ORR valutato dallo sperimentatore
PFS valutata dallo sperimentatore
DR valutata dallo sperimentatore
HRQoL valutata mediante il Questionario sulla qualità della vita a 30 voci (QLQ-C30) dell’Organizzazione europea per la ricerca e la cura del cancro (EORTC), il modulo europeo specifico per il tumore esofageo OES18 e il questionario EQ-5D-5L.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Assessment of Immunogenicity

Valutazione dell'immunogenicità

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

Yes

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

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

France

Germany

Italy

Japan

Korea, Republic of

Spain

Taiwan

United Kingdom

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:

270

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

101

F.4.2.2

In the whole clinical trial

450

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 assigned to BGB-A317, who in the opinion of the Investigator, continue to benefit from BGB-A317 at study termination, may continue treatment after discussion and agreement by the Sponsor. For these patients, BGB-A317 will be provided by the Sponsor until they can be transitioned to commercial supply.

I pazienti assegnati alla terapia con BGB-A317 che, sulla base del parere dello sperimentatore, continuano a beneficiare del medicinale sperimentale BGB-A317 alla fine dello studio, possono continuare il trattamento dopo discussione e accordo col promotore. Per questi pazienti, BGB-A317 sarà fornito dal promotore fino a quando non sarà passato in commercio.

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

2018-04-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-18

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

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Orphan Designation Number:
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