Clinical Trials Register

Summary
EudraCT Number:	2016-002349-50
Sponsor's Protocol Code Number:	M16TGA
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-06-18
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

2016-002349-50

A.3

Full title of the trial

Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an
activated TGF-β signature

Studio di fase I/II con galunisertib in combinazione con capecitabina in pazienti affetti da tumore del colon-retto avanzato refrattarioallachemioterapia e con una signature genetica TGF-β like.

A.3.1

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

Phase I/II study with galunisertib combined with chemotherapy in patients with metastasized, resistent bowle cancer and an activated TGF-beta signature.

Studio di fase I/II con galunisertib in combinazione con capecitabina in pazienti affetti da tumore del colon-retto avanzato refrattarioallachemioterapia e con una signature genetica TGF-β like.

A.3.2

Name or abbreviated title of the trial where available

Phase I/II study with galunisertib combined with chemotherapy in patients with metastasized, resiste

M16TGA: galunisertib e capecitabina nel mCRC con signature genetica TGF-beta like

A.4.1

Sponsor's protocol code number

M16TGA

A.5.4

Other Identifiers

Name:

EORTC 1615

Number:

MOTRICOLOR CT1

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	THE NETHERLANDS CANCER INSTITUTE
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly
B.4.2	Country	United States
B.4.1	Name of organisation providing support	NKI-AVL
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	The Directorate-General for Research and Innovatio
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Netherlands Cancer Institute
B.5.2	Functional name of contact point	Jan Schellens
B.5.3	Address:
B.5.3.1	Street Address	Plesmanlaan 121
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1066 CX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031205122961
B.5.5	Fax number	0031205122572
B.5.6	E-mail	j.schellens@nki.nl

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	galunisertib
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	700874-74-2
D.3.9.2	Current sponsor code	LY2157299
D.3.9.3	Other descriptive name	GALUNISERTIB
D.3.9.4	EV Substance Code	SUB126321
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	80 to 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	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)	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	CAPECITABINE
D.2.1.1.2	Name of the Marketing Authorisation holder	/
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	CAPECITABINE
D.3.2	Product code	SUB12474MIG
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITABINA
D.3.9.2	Current sponsor code	SUB12474MIG
D.3.9.3	Other descriptive name	CAPECITABINA
D.3.9.4	EV Substance Code	SUB12474MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	150 to 500
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.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

colorectal carcinoma

E.1.1.1

Medical condition in easily understood language

intestinal cancer

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	10052362
E.1.2	Term	Metastatic colorectal 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

Phase I: To determine the recommended phase 2 dose (RP2D) of galunisertib plus capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

Phase II: To determine the anti-tumor activity, as measured by response rate (RR) of galunisertib in combination with capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

Fase I: determinare la dose raccomandata per la fase 2 (RP2D) di galunisertib in combinazione con capecitabina in pazienti affetti da CRC resistente a chemioterapia con una signature genetica TGF-β like

Fase II: determinare l’attività antitumorale, misurata in base al tasso di risposta (RR) di galunisertib in combinazione con capecitabina in pazienti affetti da CRC resistente a chemioterapia con una signature genetica TGF-β like.

E.2.2

Secondary objectives of the trial

- To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events
- To assess anti-tumor activity of galunisertib in combination with chemotherapy, as measured by duration of response, time to response and, progression free survival (phase II only) and overall survival (phase II only)
- To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
- To explore genetic determinants of response to galunisertib in combination with chemotherapy, as measured by baseline molecular status of potential predictive markers of tumor response
- To explore the potential mechanism of resistance to galunisertib in combination with chemotherapy, as measured by gene alterations/expression profiles (e.g. baseline, relapse) in tumor tissue upon progression

- Caratterizzare la sicurezza e la tollerabilità di galunisertib in combinazione con regimi di chemioterapia, valutate in base ad incidenza e gravità degli eventi avversi
- Valutare l’attività antitumorale di galunisertib in combinazione con chemioterapia, misurata in base a durata della risposta, tempo alla risposta, sopravvivenza libera da progressione (solo fase II) e sopravvivenza globale (solo fase II)
- Determinare il profilo farmacocinetico di galunisertib in combinazione con chemioterapia, valutato in base alle concentrazioni plasmatiche
- Analizzare i determinanti genetici della risposta a galunisertib in combinazione con chemioterapia, valutati in base allo stato molecolare basale di potenziali marcatori predittivi di risposta del tumore
- Esplorare il potenziale meccanismo di resistenza a galunisertib in combinazione con chemioterapia, valutato in base ai profili di alterazione/espressione genica (ad es., al basale, alla recidiva) nel tessuto tumorale al momento della progr

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histological or cytological proof of CRC;
2. Disease progression or relapse upon first line of treatment (maximum lines of treatment is one for phase I and phase II of this study) for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);
3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia;
4. Age ≥ 18 years;
5. Able and willing to give written informed consent;
6. WHO performance status of ≤ 1;
7. LVEF ≥ 55%;
8. Able and willing to undergo blood sampling for PK and PD analysis;
9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment
10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;
11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);
12. Minimal acceptable safety laboratory values
a. ANC of ≥ 1.5 x 109 /L
b. Platelet count of ≥ 100 x 109 /L
c. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases
d. Renal function as defined by serum creatinine ≤1.5 x ULN
e. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);
13. Negative pregnancy test (urine or serum) for female patients with childbearing potential.

1. Conferma istologica o citologica di CRC
2. Progressione di malattia o recidiva dopo una prima linea di trattamento per CRC avanzato con chemioterapia contenente una fluoropirimidina come agente singolo o in combinazione (sono ammesse combinazioni con oxaliplatino, irinotecan, bevacizumab e cetuximab/panitumumab)
3. Documentazione scritta di signature genetica TGF-βlike, determinata mediante test validato di Agendia
4. Età 18 anni
5. Soggetto in grado di, e disponibile, a fornire consenso informato scritto, con firma del modulo di consenso informato prima dell’inizio della sperimentazione
6. Stato di validità OMS ≤1
7. FEVS ≥55%
8. Soggetto in grado di, e disponibile a sottoporsi a prelievi di sangue per l’analisi farmacocinetica (PK) e farmacodinamica (PD)
9. Soggetto in grado di, e disponibile a sottoporsi a biopsia tumorale prima dell’avvio, durante e alla fine del trattamento
10. Aspettativa di vita 3 mesi, che consenta un follow-up adeguato della valutazione della tossicità e dell’attività antitumorale
11. Malattia valutabile secondo i Criteri di valutazione della risposta nei tumori solidi (RECIST) 1.1 (malattia misurabile per la parte di fase II; per la parte di fase I è sufficiente che la malattia sia valutabile)
12. Valori minimi accettabili degli esami di laboratorio per la sicurezza
a. Conta assoluta dei neutrofili (ANC) 1,5 x 109/l
b. Conta piastrinica 100 x 109 /L
c. Funzione epatica definita da livelli sierici di bilirubina 1,5 x il limite superiore della norma (ULN), ALAT e ASAT 3,0 x ULN o ALAT e ASAT <5 x ULN nei pazienti con metastasi epatiche
d. Funzione renale definita da livelli sierici di creatinina 1,5 x ULN
e. Clearance della creatinina 50 ml/min (secondo la formula di Cockroft-Gault o la formula “Modifica della dieta nella patologia renale” [MDRD])
13. Test di gravidanza (urinario o sierico) negativo per le pazienti in età fertile

E.4

Principal exclusion criteria

1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment;
2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A>T genotype);
3. Symptomatic or untreated leptomeningeal disease;
4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;
5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart.
6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral galunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection);
7. Woman who are pregnant or breast feeding;
8. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms);
9. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed;
10. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery;
11. Active infection requiring systemic antibiotics or uncontrolled infectious disease;
12. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
13. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;
14. Known hypersensitivity to one of the study drugs or excipients.

1. Qualsiasi trattamento con farmaci sperimentali nei 30 giorni precedenti la somministrazione della prima dose di trattamento sperimentale
2. Deficit noto o sospetto di diidropirimidina deidrogenasi (genotipo mutato per DPD*2A, genotipo 1236 GA, genotipo 1679TG e genotipo 2846A>T)
3. Malattia leptomeningea sintomatica o non trattata
4. Metastasi cerebrali sintomatiche. È consentito l’arruolamento di pazienti, trattati o meno in precedenza per queste condizioni, che appaiano asintomatici in assenza di terapia corticosteroidea. Le metastasi cerebrali devono essere stabili, con verifica mediante esami di imaging (ad es., RM o TC cerebrale eseguita allo screening che non dimostri alcuna attuale evidenza di metastasi cerebrali in progressione). I pazienti non possono ricevere farmaci antiepilettici induttori enzimatici o corticosteroidi
5. Anamnesi di patologia cardiaca, tra cui infarto miocardico nei 6 mesi precedenti l’ingresso nello studio, angina pectoris instabile, insufficienza cardiaca congestizia di classe III/IV secondo la classificazione della New York Heart Association (Associazione dei cardiologi di New York) o ipertensione non controllata, anomalie cardiache maggiori, predisposizione allo sviluppo di aneurismi, inclusa anamnesi familiare di aneurismi, sindrome di Marfan, valvola aortica bicuspide o evidenza di lesione a carico dei grossi vasi del cuore
6. Compromissione della funzione gastrointestinale (GI) o patologia GI che possa alterare in modo significativo l’assorbimento di galunisertib per via orale (ad es., patologie ulcerative, nausea non controllata, vomito, diarrea, sindrome da malassorbimento, resezione dell’intestino tenue)
7. Donne in gravidanza o che allattano al seno
8. Metodi contraccettivi non affidabili. Sia gli uomini che le donne arruolati in questa sperimentazione devono acconsentire ad utilizzare un metodo contraccettivo affidabile per tutta la durata dello studio (sono metodi contraccettivi adeguati il preservativo, la sterilizzazione, altre misure contraccettive di barriera preferibilmente in combinazione con preservativi)
9. Radioterapia o chemioterapia nelle ultime 2 settimane (30 giorni per i farmaci sperimentali) prima della somministrazione della prima dose di trattamento sperimentale. È consentita la radioterapia palliativa (1 x 8 Gy)
10. Pazienti sottoposti a qualsiasi intervento chirurgico maggiore nelle ultime 2 settimane prima dell’avvio del farmaco dello studio o che non si siano ripresi completamente da un precedente intervento chirurgico
11. Infezione in fase attiva con necessità di terapia antibiotica per via sistemica o patologia infettiva non controllata
12. Pazienti con anamnesi nota di epatite B o C o con infezione nota da virus dell’immunodeficienza umana di tipo 1 (HIV-1) o 2 (HIV-2)
13. Altra condizione medica o psichiatrica o anomalia di laboratorio grave, acuta o cronica, che possa aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco dello studio o che possa interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renderebbe il paziente un candidato non idoneo per lo studio
14. Ipersensibilità nota a uno dei farmaci dello studio o degli eccipienti

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the trial

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

at the end of the trial

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

pharmacokinetic study

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

Information not present in EudraCT

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

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

Yes

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

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)

none

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	MoTriColor Consortium
G.4.3.4	Network Country	Spain

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-08-05

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