Clinical Trials Register

Summary
EudraCT Number:	2015-001909-14
Sponsor's Protocol Code Number:	APL-B-021-13
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-09-30
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

Czechia - SUKL

A.2

EudraCT number

2015-001909-14

A.3

Full title of the trial

A Phase II Study of Plitidepsin in Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

Klinické hodnocení fáze II přípravku plitidepsin u pacientů s recidivujícím nebo rezistentním angioimunoblastickým T-buněčným lymfomem

A.3.1

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

A Phase II Study of Plitidepsin in Patients with Angioimmunoblastic T-cell Lymphoma.

Klinické hodnocení fáze II přípravku plitidepsin u pacientů s angioimunoblastickým T-buněčným lymfomem

A.4.1

Sponsor's protocol code number

APL-B-021-13

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	Pharma Mar, S.A.
B.1.3.4	Country	Spain
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	Pharma Mar, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pharma Mar, S.A.
B.5.2	Functional name of contact point	Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Avd. De Los Reyes, no 1 Pol. Ind. La Mina
B.5.3.2	Town/ city	Colmenar Viejo (Madrid)
B.5.3.3	Post code	28770
B.5.3.4	Country	Spain
B.5.4	Telephone number	3491846 60 00
B.5.5	Fax number	3491846 60 03
B.5.6	E-mail	clinicaltrials@pharmamar.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	Aplidin
D.3.4	Pharmaceutical form	Powder and solvent for 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	plitidepsin
D.3.9.3	Other descriptive name	PLITIDEPSIN
D.3.9.4	EV Substance Code	SUB31204
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	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

Recidivující nebo rezistentní angioimunoblastický T-buněčný lymfom.

E.1.1.1

Medical condition in easily understood language

Angioimmunoblastic T-cell Lymphoma.

Angioimunoblastický T-buněčný lymfom.

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	10002453
E.1.2	Term	Angioimmunoblastic T-cell lymphoma refractory
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 the efficacy of plitidepsin on the basis of overall response rate (ORR) in patients with relapsing/refractory angioimmunoblastic T-cell lymphoma (AITL).

E.2.2

Secondary objectives of the trial

•To evaluate other efficacy endpoints (time-to-event parameters:
duration of response [DoR], progression-free survival [PFS], PFS at 6/12
months [PFS6/PFS12], intrapatient PFS/TTP, overall survival [OS] and
OS at 6/12 months [OS6/OS12]).
•To evaluate the safety profile of plitidepsin in this patient population.
•To characterize the pharmacokinetics (PK) of plitidepsin.
•To identify biomarkers that may be clinical endpoint surrogates for
future plitidepsin studies or that may be predictive of plitidepsin activity.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1)Voluntary written informed consent of the patient (both to participate
in the study and to provide biopsy samples) obtained before any studyspecific
procedure.
2)Age ≥ 18 years.
3)Eastern Cooperative Oncology Group (ECOG) performance status (PS)
≤ 2.
4)Life expectancy ≥ 3 months.
5)Histologically confirmed diagnosis of R/R AITL (eligibility needs to be
confirmed by central pathological review.*)
6)At least a two-week washout period since the end of the last therapy
(six weeks for a prior nitrosourea-containing regimen), recovery to
grade ≤ 1 from any non-hematological adverse event (AE) derived from
previous treatment (excluding alopecia).
7)Adequate bone marrow (BM), renal, hepatic, and metabolic function
(assessed ≤ 14 days before inclusion in the study):
a)Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
Screening of ANC should be independent of granulocyte-colony
stimulating factor (G-CSF) support for at least one week and of
pegylated G-CSF for at least two weeks.
b)Platelet count ≥ 75 × 109/L.
c)Hemoglobin ≥ 9 g/dL.
Patients may receive red blood cells (RBC) and/or erythropoietin (EPO)
and/or platelet transfusions in accordance with institutional guidelines.
d)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
≤ 3.0 × the upper limit of normal (ULN).
e)Total bilirubin ≤ 1.5 × ULN.
f)Alkaline phosphatase (ALP) ≤ 3.0 × ULN (< 5 × ULN if isolated ALP
increase, i.e., without ALT/AST or bilirubin increase).
g)Calculated creatinine clearance (CrCL) ≥ 30 mL/minute (Cockcroft-
Gault formula).
h)Creatine phosphokinase (CPK) ≤ 2.5 × ULN.
i)Albumin ≥ 2.5 g/dL.
8)Left ventricular ejection fraction (LVEF) by echocardiogram
(ECHO) or multiple-gated acquisition (MUGA) scan within
normal range (according to institutional standards).
* Patient inclusion can be approved based on local histopathological
report(s). Eligibility will be confirmed using diagnosis and/or relapse
biopsy specimens submitted for central pathological review prior to each
futility analysis/end of the study.

1) Dobrovolný písemný informovaný souhlas pacienta (s účastí v klinickém hodnocení a s poskytnutím bioptických vzorků) získaný ještě před vyšetřeními v rámci klinického hodnocení.
2) Věk ≥ 18 let.
3) Výkonnost ≤ 2 podle stupnice Východní skupiny pro spolupráci v onkologii (ECOG).
4) Očekávaná doba dožití ≥ 3 měsíce.
5) Histologicky potvrzená diagnóza R/R AITL (Způsobilost musí být potvrzena centrálním patologem. Zařazení pacienta do klinického hodnocení může být schváleno na základě místní histopatologické zprávy. Způsobilost bude potvrzována na základě bioptických vzorků získaných při stanovení diagnózy a/nebo při relapsu onemocnění a poskytnutých k vyhodnocení centrálním patologem před každou analýzou neúčinnosti/na konci klinického hodnocení.).
6) Minimálně dvoutýdenní vymývací fáze od konce poslední léčby (šestitýdenní v případě režimu obsahujícího nitrosomočovinu), zotavení z případné nehematologické nežádoucí příhody (AE) vyvolané předchozí léčbou (kromě alopecie) na stupeň ≤ 1.
7)Přiměřená funkce kostní dřeně, ledvinová, jaterní a metabolická funkce (posuzovaná ≤ 14 dnů před zařazením do klinického hodnocení):
a)Absolutní počet neutrofilů (ANC) ≥ 1,0 x 109/l.
Hodnota ANC by měla být stanovena nezávisle na podpůrném podávání faktoru stimulujícího granulocytární kolonie (G-CSF) po dobu alespoň jednoho týdne a pegylovaného G-CSF po dobu alespoň dvou týdnů.
b)Počet krevních destiček ≥ 75 × 109/l.
c)Hemoglobin ≥ 9 g/dl.
Pacienti mohou dostávat transfuze červených krvinek a/nebo erytropoetinu (EPO) a/nebo krevních destiček v souladu se směrnicemi platnými v místním zdravotnickém zařízení.
d)Aspartát aminotransferáza (AST) nebo alanin aminotransferáza (ALT) ≤ trojnásobek horní hranice normálního rozmezí.
e)Celkový bilirubin ≤ 1,5násobek horní hranice normálního rozmezí.
f)Alkalická fosfatáza (ALP) ≤ trojnásobek horní hranice normálního rozmezí (< pětinásobek horní hranice normálního rozmezí, pokud se jedná o ojedinělé zvýšení hodnoty ALP, tj. bez zvýšení hodnot ALT/AST nebo bilirubinu).
g)Vypočítaná clearance kreatininu (CrCL) ≥ 30 ml/min (Cockcroftův-Gaultův vzorec).
h)Kreatin fosfokináza (CPK) ≤ 2,5násobek horní hranice normálního rozmezí.
i)Albumin ≥ 2,5 g/dl.
8)Ejekční frakce levé komory (LVEF) na echokardiogramu (ECHO) nebo při vícenásobném akvizičním snímkování (MUGA) v normálním rozmezí (podle metodiky zdravotnického zařízení).

E.4

Principal exclusion criteria

1)Prior treatment with plitidepsin.
2)Concomitant diseases/conditions:
a)History or presence of angina, myocardial infarction, clinically relevant
valvular heart disease, uncontrolled hypertension, or congestive heart
failure within the previous 12 months.
b)Symptomatic arrhythmia (excluding grade ≤ 2 anemia-related sinusal
tachycardia) or any arrhythmia requiring ongoing treatment, and/or
prolonged grade ≥ 2 QT-QTc, or presence of unstable atrial fibrillation.
Patients with stable atrial fibrillation on treatment are allowed provided
they do not meet any other cardiac or prohibited drug exclusion
criterion.
c)Active uncontrolled infection. Active hepatitis B or C virus (HBV or
HCV), or human immunodeficiency virus (HIV) infection.
d)Morphological or cytological features of myelodysplasia and/or postchemotherapy
aplasia on BM assessment.
e)Myopathy > grade 2 or any clinical situation that causes significant
and persistent elevation of CPK (> 2.5 × ULN in two different
determinations performed one week apart).
f)Limitation of the patient's ability to comply with the treatment or
follow-up requirements.
g)Diagnosis of another invasive malignancy unless free of disease for at least three years following therapy with curative intent. Patients with
early-stage basal cell or squamous cell skin cancer, cervical
intraepithelial neoplasia, cervical carcinoma in situ, or superficial
bladder cancer, may be eligible to participate at the Investigator's
discretion.
h)Any other major illness that, in the Investigator's judgment, will
substantially increase the risk associated with the patient's participation
in this study.
3)Central nervous system (CNS) involvement.
4)Women who are pregnant or breast feeding. Fertile patients (men and
women) who are not using an effective method of contraception. All
patients (men and women) must agree to use an effective contraceptive
measure (if applicable) up to six months after treatment discontinuation.
5)Concomitant medications that include corticosteroids, chemotherapy,
or other therapy that is or may be active against AITL, within the two
weeks prior to treatment start. Concurrent corticosteroids are allowed,
provided they are administered at an equivalent prednisone dose of ≤ 10 mg daily, as premedication for blood products and/or for the relief of the symptoms derived from the disease.
6)Major upper gastrointestinal bleeding episode occurring during the
previous year before screening.
7)Known hypersensitivity to any of plitidepsin’s formulation components (see Study Drug Formulation).

1)Předchozí souběžná léčba plitidepsinem.
2)Souběžná onemocnění / souběžné stavy:
a)Anamnéza nebo přítomnost anginy pectoris, infarktu myokardu, klinicky významného onemocnění srdečních chlopní, nezvládaného vysokého krevního tlaku nebo městnavého srdečního selhání v posledních 12 měsících.
b)Symptomatická srdeční arytmie (s výjimkou sinusové tachykardie stupně ≤ 2 související s anémií) nebo jakékoli poruchy srdečního rytmu vyžadující další léčbu a/nebo dlouhodobé prodloužení intervalu QT-QTc stupně ≥ 2 nebo nestabilní fibrilace síní. Pacienti se stabilní fibrilací síní podstupující léčbu se budou moci klinického hodnocení zúčastnit, pokud nebudou splňovat žádné jiné vylučovací kritérium týkající se srdečních onemocnění nebo zakázaných léků.
c)Nezvládaná aktivní infekce. Aktivní infekce virem hepatitidy B nebo C (HBV nebo HCV) nebo virem lidské imunitní nedostatečnosti (HIV).
d)Morfologické nebo cytologické vlastnosti myelodysplazie a/nebo postchemoterapeutická aplazie při vyšetření kostní dřeně.
e)Myopatie > stupeň 2 nebo případný jiný klinický stav, který způsobuje významné a přetrvávající zvýšení hodnoty CPK (> 2,5násobek horní hranice normálního rozmezí při dvou vyšetřeních v odstupu jednoho týdne).
f)Omezená schopnost pacienta dodržovat požadavky léčby nebo sledování po léčbě.
g)Diagnóza jiného invazivního zhoubného onemocnění, pokud pacient není bez onemocnění už alespoň tři roky po léčbě s léčebným záměrem. Klinického hodnocení se podle uvážení zkoušejícího lékaře budou moci účastnit pacienti s bazocelulárním nebo spinocelulárním karcinomem v raném stadiu, s cervikální intraepiteliální neoplazií, s cervikálním karcinomem in situ nebo s povrchovým karcinomem močového měchýře.
h)Jakékoli závažné onemocnění, které by podle úsudku zkoušejícího lékaře mohlo výrazně zvyšovat rizika spojená s účastí pacienta v tomto klinickém hodnocení.
3)Zasažení centrální nervové soustavy (CNS).
4)Těhotné nebo kojící ženy. Fertilní pacienti (muži i ženy) ne(po)užívající účinnou antikoncepci. Všichni pacienti (muži i ženy) se proto budou muset zavázat, že budou ještě šest měsíců po skončení léčby (po)užívat účinnou antikoncepci (bude-li to v jejich případě relevantní).
5)Souběžná léčba v posledních dvou týdnech před zahájením hodnocené léčby zahrnující podávání kortikosteroidů, chemoterapie nebo jiných léků, které působí nebo by mohly působit proti AITL. Současné podávání kortikosteroidů je dovoleno za předpokladu, že jsou podávány v dávce ekvivalentní ≤ 10 mg prednisonu denně jako premedikace pro krevní přípravky a/nebo pro úlevu od příznaků odvozených od onemocnění.
6)Závažné krvácení do horní části zažívacího traktu v posledním roce před vstupními vyšetřeními.
7)Známá přecitlivělost na jakoukoli složku lékové formy plitidepsinu (viz složení hodnoceného přípravku).

E.5 End points

E.5.1

Primary end point(s)

Overall response rate (ORR), defined as the percentage of patients with remission, either complete (CR) or partial remission (PR), according to the Lugano classification response criteria per independent review.
An external IRC will assign the objective response and a progression or censoring date for each patient according to a predefined algorithm provided in a separate charter.

E.5.1.1

Timepoint(s) of evaluation of this end point

Two futility analyses of the primary endpoint (ORR according to the Lugano classification criteria and per IRC) are planned around six months after approximately 25% and 50% of eligible patients (i.e., 15 and 30 patients respectively with AITL confirmed by central pathological review) have been treated.

E.5.2

Secondary end point(s)

*ORR per Investigator assessment (IA).
*CR rate, defined as the percentage of patients with complete remission according to the Lugano classification per IRC and per IA.
*Duration of response (DoR), defined as the time from the date when the remission criteria (PR or CR, whichever is first achieved) are fulfilled to the first date when PD, recurrence or death (due to any cause) is documented. Response will be assessed according to Lugano classification and per IRC and IA.
*Progression-free survival (PFS), defined as the time from the date of first drug administration to the date of PD, death (of any cause), or last tumor evaluation per IRC and IA.
*Progression-free survival at 6/12 months (PFS6/PFS12), defined as the Kaplan-Meier estimate of the percentage of patients who are progression-free at six/twelve months after the first drug administration per IRC and IA.
*Intrapatient PFS/TTP, defined as the ratio of PFS achieved with the experimental treatment versus prior last TTP in the R/R setting.
*Overall survival (OS), defined as the time from the date of the first dose to the date of death (of any cause) or last patient contact.
*Overall survival at 6/12 months (OS6/OS12), defined as the Kaplan-Meier estimate of the percentage of patients who are alive at six/twelve months after first drug administration.
*Treatment safety [AEs, serious adverse events (SAEs) and laboratory abnormalities] graded according to the NCI-CTCAE, v.4. Dose reductions, omitted doses or cycle delays due to treatment-related AEs, and reasons for treatment discontinuations will be analyzed.
*Pharmacokinetics (PK), samples for PK analysis will be obtained during Cycle 1 exclusively.
*Exploratory Biomarker Analysis, biopsy samples (initial and relapse) and blood samples will be analyzed in order to examine any correlation of efficacy with molecular markers related to the mechanism of action of plitidepsin or to the pathogenesis of the disease.

A total of 60 patients with AITL confirmed by central pathological review will be treated, 19 or more responders will be needed to get an overall estimate for response rate higher than 30% and its lower limit for the 95% confidence interval (CI) greater than 20% (31.7% CI95% 20.3?45.0% following the binomial distribution).

E.5.2.1

Timepoint(s) of evaluation of this end point

During the study and in the Independent Review Committee meetings.

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

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker Analysis.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

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

United States

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

12 months after the last patients inclusion. If there are patients still being treated at the planned cutoff date, the actual cutoff date will be the date when those patients have completed the ongoing treatment cycle and the corresponding EOT visit.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

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)

After EOT, patients will be followed every four weeks until resolution of all toxicities (if any). Patients who discontinue treatment without disease progression will be followed every four months (+ two weeks) for the first two years of follow-up, and every six months (+ two weeks) thereafter unless clinically indicated, until PD, start of other antitumor therapy, death or the date of study termination (clinical cutoff), whichever occurs first.

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

2016-09-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-23

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-07-02

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IMP with orphan designation in the indication
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