Clinical Trials Register

Summary
EudraCT Number:	2015-003400-24
Sponsor's Protocol Code Number:	I3Y-MC-JPBZ
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

2015-003400-24

A.3

Full title of the trial

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physician¿s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

monarcHER: Studio di fase II, randomizzato, multicentrico, in aperto, a tre bracci, volto a confrontare l¿efficacia di abemaciclib in associazione a trastuzumab con o senza fulvestrant rispetto alla chemioterapia standard scelta dal medico pi¿ trastuzumab nelle donne affette da carcinoma mammario localmente avanzato o metastatico HR+, HER2+

A.3.1

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

A Study of Abemaciclib plus Trastuzumab with or without Fulvestrant in Participants with HR+, HER2+ Metastatic Breast Cancer.

Uno studio di abemaciclib pi¿ trastuzumab con o senza fulvestrant in pazienti con carcinoma mammario metastatico HR+, HER2+

A.3.2

Name or abbreviated title of the trial where available

monarcHER

A.4.1

Sponsor's protocol code number

I3Y-MC-JPBZ

A.5.4

Other Identifiers

Name:

I3Y-MC-JPBZ

Number:

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
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	Eli Lilly and Company
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	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.4	Telephone number	00390554257386
B.5.5	Fax number	00390554257348
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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	abemaciclib
D.3.2	Product code	LY2835219
D.3.4	Pharmaceutical form	Capsule, hard
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	abemaciclib
D.3.9.2	Current sponsor code	LY2835219
D.3.9.3	Other descriptive name	abemaciclib
D.3.9.4	EV Substance Code	SU171907
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Yes
D.2.1.1.1	Trade name	Faslodex
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
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	Fulvestrant
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FULVESTRANT
D.3.9.2	Current sponsor code	FULVESTRANT
D.3.9.4	EV Substance Code	SUB13933MIG
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	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	Herceptin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration 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	Trastuzumab
D.3.2	Product code	Trastuzumab
D.3.4	Pharmaceutical form	Powder for solution for injection
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	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	TRASTUZUMAB
D.3.9.3	Other descriptive name	TRASTUZUMAB
D.3.9.4	EV Substance Code	SUB12612MIG
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	120
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	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	Yes
D.3.11.13.1	Other medicinal product type	humanised IgG1 monoclonal antibody produced by mam

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

Hormone receptor positive, Her2 positive advanced breast cancer

Recettore ormonale positivo, carcinoma mammario positivo avanzato HER2+

E.1.1.1

Medical condition in easily understood language

Metastatic breast cancer

Carcinoma mammario metastatico

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	10031325
E.1.2	Term	Oth and unspec disorder of breast assoc with childbirth, delivered, with ment of postpar comp
E.1.2	System Organ Class	100000004872

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	10027475
E.1.2	Term	Metastatic breast cancer
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

The primary objective of this study is to compare the efficacy of abemaciclib plus trastuzumab plus fulvestrant and abemaciclib plus trastuzumab to standard-of-care single-agent chemotherapy of physician¿s choice plus trastuzumab with respect to progression free survival (PFS).

L¿obiettivo primario dello studio ¿ confrontare l¿efficacia di abemaciclib pi¿ trastuzumab pi¿ fulvestrant e di abemaciclib pi¿ trastuzumab con la chemioterapia monoagente standard scelta dal medico pi¿ trastuzumab in termini di sopravvivenza libera da progressione (PFS)

E.2.2

Secondary objectives of the trial

To review overall survival, objective response rate, duration of response, disease control rate, clinical benefit rate, safety and tolerability of abemaciclib, treatment impact on pain, disease symptoms and overall quality of life, pharmacokinetics of abemaciclib and relationship between abeamciclib, trastuzumab and fulvestrant exposure and clinical outcomes

¿ Tasso di sopravvivenza globale (OS) a 1, 2 e 3 anni
¿ Tasso di risposta obiettiva (ORR)
¿ Durata della risposta (DoR)
¿ Tasso di controllo della malattia
¿ Tasso di beneficio clinico
¿ Sicurezza e tollerabilit¿ di abemaciclib in associazione a trastuzumab e fulvestrant
¿ Impatto su dolore, sintomi della malattia e qualit¿ complessiva della vita
¿ Farmacocinetica (PK) di abemaciclib e dei relativi metaboliti, di fulvestrant e trastuzumab nella popolazione di pazienti target
¿ Rapporto tra esposizione ad abemaciclib, trastuzumab e fulvestrant e risposta per gli endpoint di sicurezza ed efficacia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have diagnosis of HR+, HER2+ metastatic breast cancer on the primary tumor or metastatic lesion
2. Have unresectable locally advanced recurrent breast cancer or metastatic breast cancer
3. Have adequate tumor tissue available and collected prior to randomization
4. Have previously received at least two HER2 directed therapies for advanced disease
5. Must have received trastuzumab emtansine (TDM1) in any disease setting
6. Must have received a taxane in any disease setting
7. Have discontinued all previous therapies for cancer (except trastuzumab) for at least 21 days for myelosuppressive agents or 14 days for non-myelosupprevice agents
8. Have postmenopausal status
9. Have performance status of 0 to 1 on the ECOG scale
10. Must have LVEF of 50% or higher at baseline

1] avere una diagnosi di carcinoma mammario avanzato HR+, HER2+; [2] essere affetti da carcinoma mammario recidivante localmente avanzato non resecabile o carcinoma mammario metastatico; [3] avere a disposizione un adeguato campione di tessuto tumorale (biopsia di recente acquisizione; tessuto diversamente archiviato) prelevato prima della randomizzazione [4] essere stati sottoposti in precedenza ad almeno 2 terapie mirate a HER2 per malattia avanzata e avere ricevuto T-DM1 nell’ambito del trattamento di un qualsiasi quadro patologico; [5] avere ricevuto T-DM1 nell’ambito del trattamento di un qualsiasi quadro patologico; [6] avere ricevuto un taxano nell’ambito del trattamento di un qualsiasi quadro patologico; [7] avere interrotto tutte le pregresse terapie per carcinoma, eccetto trastuzumab, da almeno 21 giorni per gli agenti mielosoppressori prima di ricevere il farmaco in studio [8] presentare uno stato post-menopausale [9] vere un performance status (PS) sulla scala ECOG (Eastern Cooperative Oncology Group) compreso tra 0 e 1 [10] presentare al basale una frazione di eiezione ventricolare sinistra (LVEF) pari o superiore al 50%

E.4

Principal exclusion criteria

1. Have visceral crisis
2. Known CNS metastases that are untreated, symptomatic or require steroids to control symptoms
3. Received prior treatment with any CDK4 or CDK6 inhibitor [8]
avere un’anamnesi delle seguenti condizioni nei precedenti 12 mesi: sincope di eziologia cardiovascolare, tachicardia ventricolare, fibrillazione ventricolare o arresto cardiaco improvviso

4. Have had major surgery within 14 days prior to randomization
5. Received treatment with a drug that has not received regulatory approval for any indication within 14 to 21 days of randomization for non-myelosuppressive or non-myelosupprevice agent, respectively
6. Have serious preexisting medical conditions that would preclude participation in this study
7. Have a history within the last 6 months of symptomatic congestive heart failure, myocardial infarction or unstable angina
8. Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest

[1] presentare crisi viscerali [2] presentare metastasi note a carico del sistema nervoso centrale (SNC) non trattate, sintomatiche o necessitanti di terapia steroidea per il controllo dei sintomi [3]
avere ricevuto un pregresso trattamento con un qualsiasi inibitore CDK 4 e CDK 6 [4] essere state sottoposte a chirurgia maggiore nei 14 giorni precedenti la randomizzazione per consentire la guarigione post-operatoria della ferita chirurgica e del sito/i chirurgico/i [5] avere ricevuto un pregresso trattamento con un farmaco che gli enti regolatori non hanno approvato per alcuna indicazione nei 14 o 21 giorni precedenti la randomizzazione rispettivamente per un agente non mielosoppressore o mielosoppressore [6]
essere affetti da pregresse condizioni cliniche serie che, secondo il giudizio dello sperimentatore, precluderebbero la partecipazione allo studio [7]
avere un’anamnesi di insufficienza cardiaca congestizia sintomatica, infarto del miocardio o angina instabile manifestatisi nei precedenti 6 mesi

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS)

Sopravvivenza libera da progressione

E.5.1.1

Timepoint(s) of evaluation of this end point

One planned primary analysis for PFS performed after 165 events have been observed. Within 28 days of randomization, baseline tumor assessment will be performed for each patient. Repeat scans will be done every 6 weeks for 36 weeks from first dose of therapy, then every 9 weeks and within 14 days of clinical progression.

È stata osservata un'analisi primaria pianificata per PFS eseguita dopo 165 eventi. Entro 28 giorni dalla randomizzazione, verrà eseguita la valutazione del tumore al basale per ciascun paziente. Ripetute scansioni saranno eseguite ogni 6 settimane per 36 settimane dalla prima dose di terapia, poi ogni 9 settimane e entro 14 giorni dalla progressione clinica.

E.5.2

Secondary end point(s)

OS rate, ORR, DoR, disease control., clinical benefit rate, safety and tolerability, impact on pain, disease symptom

OS rate, ORR, DoR, controllo della malattia., tasso di beneficio clinico, sicurezza e tollerabilità, impatto sul dolore, sintomo della malattia

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to a total of 2 interim analysis and a final analysis for OS may be performed if PFS is significant for both abemaciclib arms. Health outcome scales are administered day 1 of each cycle.

Fino a un totale di 2 analisi intermedie e un'analisi finale per OS può essere eseguita se PFS è significativo per entrambi i bracci di abemaciclib. Le scale dei risultati di salute vengono sottomessi il giorno 1 di ciascun ciclo.

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of life, pain management and disease symptom control

qualit¿ della vita, controllo della gestione del dolore e dei sintomi della malattia

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

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

Yes

E.8.2.3.1

Comparator description

Trastuzumab più la scelta da parte del medico di chemioterapia agente singolo come standard di cura

Trastuzumab plus physician's choice of standard of care single agent chemotherapy

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

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

Brazil

Canada

Korea, Republic of

Mexico

United States

Belgium

France

Germany

Greece

Italy

Spain

United Kingdom

Argentina

E.8.7

Trial has a data monitoring committee

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:

160

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

225

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)

Upon discontinuation the following will occur: physical exam; vitals; ECOG performance status; survival information; adverse events collection; concomitant medications; central hematology/chemistry and biomarker plasma sample collection; ECGl tumor tissue collection and health outcomes scales.
Postdiscontinuation follow-up will be approximately every 9 weeks until the patient's death or overall study completion.

Dopo l'interruzione si verifica quanto segue: esami fisici, segni vitali, ECOG, informazioni sulla sopravvivenza, raccolta degli eventi avversi, medicazioni concomitanti, raccolta dei campioni di plasma per ematologia e chimica e biomarcatori, raccolta del tessuto tumorale, e risultati scale di salute. f-up succesivo all'interruzione avverr¿ circa ogni 9settimane fino al decesso del paziente o al completamento dello studio

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

2016-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-07

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

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Clinical trials