Clinical Trials Register

Summary
EudraCT Number:	2017-001016-11
Sponsor's Protocol Code Number:	SAKK17/16
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:	2021-01-13
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

2017-001016-11

A.3

Full title of the trial

Lurbinectedin Monotherapy in Patients with Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial

A.3.1

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

Study with Lurbinectedin monotherapy in patients with mesothelioma

Studio con lurbinectedina in monoterapia in pazienti con mesotelioma

A.3.2

Name or abbreviated title of the trial where available

SAKK 17/16

A.4.1

Sponsor's protocol code number

SAKK17/16

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	SAKK
B.1.3.4	Country	Switzerland
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	Pharma Mar SA
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	SAKK
B.5.2	Functional name of contact point
B.5.3	Address:
B.5.3.1	Street Address	Effingerstrasse 33
B.5.3.2	Town/ city	Berna
B.5.3.3	Post code	CH - 3008
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41 31 508 41 51
B.5.5	Fax number	+41 31 389 92 00
B.5.6	E-mail	Martina.Schneider@sakk.ch

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	Lurbinectedina
D.3.2	Product code	PM01183
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	Lurbinectedin
D.3.9.1	CAS number	497871-47-3
D.3.9.2	Current sponsor code	PM01183
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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

Pleural Mesothelioma

Mesotelioma pleurico

E.1.1.1

Medical condition in easily understood language

Pleural Tumor

Tumore della pleura

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	10059518
E.1.2	Term	Pleural mesothelioma malignant
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 assess efficacy and safety of lurbinectedin monotherapy in patients with progressive malignant mesothelioma

Valutare l¿efficacia e la sicurezza di una monoterapia con lurbinectedina in pazienti con mesotelioma maligno in progressione.

E.2.2

Secondary objectives of the trial

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

Pharmacogenetics
Version: 1.0
Date: 29/05/2017
Title: Translational Research
Objectives: The objective of this subproject is to identify the different variants and in particular deleterious
variants of genes related to the mechanism of action of lurbinectedin

Farmacogenetica
Versione: 1.0
Data: 29/05/2017
Titolo: Ricerca Traslazionale
Obiettivi: L'obiettivo di questo sottoprogetto ¿ quello di individuare le diverse varianti e in particolare di quelle varianti deleterie di geni legati al meccanismo d'azione di lurbinectedina

E.3

Principal inclusion criteria

- Histologically confirmed malignant mesothelioma (all histologies);
- Progression on or after one line of platinum-based combination chemotherapy;
- = 1 line of treatment with an immune checkpoint inhibitor;
- Prior systemic treatment stopped at least 4 weeks before registration;
- Measurable or evaluable disease according to the modified RECIST criteria for malignant pleural mesothelioma;
- ECOG PS = 1;
- Adequate bone marrow function, hepatic function and renal function.

- Mesotelioma maligno confermato istologicamente (tutte le istologie);
- Progressione durante o dopo una linea di trattamento chemioterapico basato sulla combinazione con platino;
- = 1 linea di trattamento con un inibitore del checkpoint immunitario;
- Precedente trattamento sistemico interrotto almeno 4 settimane prima dell’inclusione;
- Malattia misurabile o valutabile in base ai criteri RECIST modificati per il mesotelioma pleurico maligno;
- ECOG PS = 1;
- Funzioni del midollo osseo, epatica e renale adeguate.

E.4

Principal exclusion criteria

- Known brain or leptomeningeal metastases;
- More than one previous line of chemotherapy;
- Concomitant use of other anti-cancer drugs, anti-cancer surgery or radiotherapy except for local pain control and/or dyspnea (e.g. pleurodesis);
- Severe or uncontrolled endocrinopathy due to previous immune checkpoint inhibitor treatment (if applicable);
- Known history of human immunodeficiency virus or active chronic hepatitis C or B virus infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.

- Metastasi nota del cervello o leptomeningee;
- Più di una precedente linea di chemioterapia;
- Uso concomitante di altri farmaci antitumorali, di interventi chirurgici per il cancro o di radioterapia ad eccezione di quella utilizzata per il controllo del dolore locale e/o della dispnea (ad es. Pleurodesi);
- Endocrinopatia grave o non controllata causata da un precedente trattamento con un inibitore del checkpoint immunitario (se applicabile);
- Presenza in anamnesi di infezioni da virus da immunodeficienza umana o di infezioni croniche attive da virus dell'epatite C o B o di qualsiasi infezione sistemica attiva non controllata.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival (PFS) at 12 weeks

L’intervallo di tempo libero da progressione (PFS) alla 12a settimana

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

Progression-free survival (PSF); Objective response (OR); Disease Control rate (DCR); Overall Survival (OS); Time to treatment failure (TTF); Adverse events

Sopravvivenza libera da progressione (PFS); Risposta obiettiva (OR); Percentuale di controllo della malattia (DCR) ; Sopravvivenza globale (OS); Intervallo di tempo al fallimento del trattamento (TTF); Eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

From registration to one of the following events, whichever occurs first:
¿ Relapse or progression
¿ Death due to any cause; During Trial treatment; 12 weeks; Until death for any cause; Until treatment discontinuation due to any reason; From registration until 30 days after last administration of lurbinectedin or until the start of a new antitumor therapy, whichever occurs first.

Dall'arruolamento fino a uno dei seguenti eventi, a seconda di quello che si verifica per primo:
- ricaduta o progressione
- decesso per qualsiasi causa; Durante il trattamento in studio; 12 settimane; Fino al decesso per qualsiasi causa; Fino a interruzione del trattamento per qualsiasi causa; Dall'arruolamento fino a 30 giorni dopo l'ultima somministrazione di lurbinectedina o fino all'inizio di una nuova terapia antiotumorale, a seconda di ci¿ che si verifica per primo

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

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

Italy

Switzerland

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:

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)

Patients will be treated according to the local clinical practice

I pazienti saranno trattati in accordo alla pratica clinica locale

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

2018-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-31

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

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