Clinical Trials Register

Summary
EudraCT Number:	2018-004571-12
Sponsor's Protocol Code Number:	ISG-ERASING
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:	2021-06-17
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

2018-004571-12

A.3

Full title of the trial

ERibulin in Advanced Solitary fibrous tumor, an ItaliaN sarcoma Group phase II study
(ERASING)

Tumore Fibroso solitario: studio di fase II su eribulina in pazienti con malattia avanzata

A.3.1

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

Trial in advanced Solitary Fibrous Tumor (SFT)

Studio clinico nel Tumore Fibroso Solitario (TFS)

A.3.2

Name or abbreviated title of the trial where available

ERASING

A.4.1

Sponsor's protocol code number

ISG-ERASING

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	ITALIAN SARCOMA GROUP
B.1.3.4	Country	Italy
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	Eisai Italy
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Italian Sarcoma Group
B.5.2	Functional name of contact point	Clinical Trial Unit
B.5.3	Address:
B.5.3.1	Street Address	Via Ca' Ricchi 33
B.5.3.2	Town/ city	San Lazzaro di Savena (BO)
B.5.3.3	Post code	40068
B.5.3.4	Country	Italy
B.5.4	Telephone number	3335359192
B.5.6	E-mail	clinicaltrials@italiansarcomagroup.org

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	Yes
D.2.1.1.1	Trade name	HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Eribulina
D.3.2	Product code	[30058]
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERIBULINA
D.3.9.1	CAS number	253128-41-5
D.3.9.2	Current sponsor code	Eribulina
D.3.9.4	EV Substance Code	SUB31126
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	440
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

Advanced Solitary Fibrous Tumor (SFT)

Tumore Fibroso Solitario in fase avanzata

E.1.1.1

Medical condition in easily understood language

Advanced Solitary Fibrous Tumor (SFT)

Tumore Fibroso Solitario in fase avanzata

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	HLT
E.1.2	Classification code	10041298
E.1.2	Term	Soft tissue sarcomas histology unspecified
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 explore the activity of eribulin in 2nd or 3rd line, in adult patients with advanced SFT. Therefore, with reference to a study population of patients with progressive locally advanced or metastatic SFT pretreated with one or two line of medical treatment, the primary end-point of the study will be to assess:
Overall tumor Response Rate, according to RECIST v 1.1

Tasso di risposta tumorale (Overall Tumor Response Rate) secondo i criteri RECIST 1.1

E.2.2

Secondary objectives of the trial

1. Choi Response Rate
2. Overall Survival (OS)
3. Progression Free Survival (PFS)
4. Clinical Benefit Rate
5. Duration of response
6. Safety

1) Tasso di risposta secondo i criteri Choi
2)Sopravvivenza globale (OS)
3) Sopravvivenza libera da progressione (PFS)
4)Tasso di beneficio clinico
5)Durata della risposta
6) Sicurezza del trattamento

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

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Biological optional sub.study
Vers 1.0 of 19Dec2018 (included into the main protocol)

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sotto studio opzionale biologico
Versione 1.0 del 19/12/2018 (incluso nel protocollo dello studio)

E.3

Principal inclusion criteria

1. The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses
2. Age =18 years
3. Histological centrally and molecularly confirmed diagnosis of STAT6 positive solitary fibrous tumor (inclusive of the last available tumor sample or fresh biopsy); a paraffin embedded tumor block is required.
4. Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
5. Measurable or evaluable disease with RECIST 1.1
6. Evidence of progression by RECIST 1.1 during the 6 months before study entry
7. Patients must be pre-treated with at least one prior medical anticancer treatment line for the advanced phase of disease (both cytotoxic chemotherapy or target treatment allowed) and with a maximum of 2 lines.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status <=2
9. Adequate bone marrow function
10. Adequate organ function
11. Cardiac ejection fraction =50% as measured by echocardiogram
12. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.

leggere e comprendere il modulo di consenso informato e deve fornire il proprio consenso informato scritto prima di qualsiasi procedura specifica per lo studio
2) Età = 18 anni
3) Diagnosi istologica e molecolare (centralmente confermata) TFS positivo per STAT6. Per l’inclusione nello studio è necessario avere a disposizione l’inclusione in paraffina di materiale tumorale di biopsia pre-trattamento (se effettuata per pratica clinica) o del più recente materiale tumorale di archivio.
4) Malattia localmente avanzata (come nel caso in cui non sia fattibile una resezione chirurgica radicale della malattia localizzata, oppure non sia accettata dal paziente o suscettibile di divenire meno demolitiva, più fattibile o facile, dopo citoriduzione) e/o metastatica.
5) Malattia misurabile secondo i criteri RECIST 1.1
6) Evidenza di progressione secondo i criteri RECIST 1.1 nei 6 mesi precedenti l’ingresso in studio.
7) I pazienti debbono essere stati precedentemente pre-trattati con almeno un trattamento antitumorale per la malattia avanzata (come linee precedenti sono permesse sia chemioterapia citotossica che con agenti target). Sono ammessi al massimo 2 precedenti linee di malattia avanzata.
8) ECOG <= 2
9) Adeguata funzionalità midollare
10) Adeguata funzionalità di organo
11) Frazione di eiezione cardiaca = 50% misurata mediante ecocardiogramma
12) Le pazienti di sesso femminile in età fertile devono avere un test di gravidanza negativo entro 7 giorni prima dell'inizio di ogni ciclo di chemioterapia.
Le donne in post-menopausa devono essere amenorroiche da almeno 12 mesi per essere considerate potenzialmente non fertili.
I pazienti maschi e femmine potenzialmente fertili devono accettare di utilizzare un metodo efficace di controllo delle nascite durante lo studio

E.4

Principal exclusion criteria

1. Naïve patients
2. >2 line of anticancer treatment
3. Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing,
4. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
5. Previous radiotherapy to 25 % of the bone marrow
6. Major surgery within 21 days prior to study entry
7. Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
8. Pregnancy or breast feeding
9. Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment. Unstable angina or myocardial infarction within 6 months of enrolment, Serious and potentially life-threatening arrhythmia
10. Subjects with a high probability of Long QT Syndrome or QTc interval prolongation of more than or equal to 501 msec on at least two separate
electrocardiograms (ECGs), following correction of any electrolyte imbalance
11. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
12. Known history of human immunodeficiency virus infection
13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
14. Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment
15. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
17. Subjects who have not recovered from acute toxicities as a result of prior anti-cancer
therapy to = Grade 1, according to Common Terminology Criteria for Adverse Events
(CTCAE), except for peripheral neuropathy (see Exclusion 18) and alopecia.
18. Pre-existing peripheral neuropathy > CTCAE Grade 2.
19. Expected non-compliance to medical regimens
20. Subjects with known central nervous system (CNS) metastases.

1) Pazienti na¿ve
2) Più di due precedenti linee di trattamento antitumorale
3) Trattamento nei 21 giorni precedenti il primo giorno di assunzione di eribulina, con qualsiasi agente antitumorale sperimentale o meno. Sono esclusi i pazienti per i quali la tossicità dei precedenti trattamenti non è stata risolta.
4) Trattamento di radioterapia nei 14 giorni precedenti al primo giorno di assunzione di eribulina.
5) Precedente radioteria che ha conivolto il midollo osseo per il 25% (o oltre)
6) Chirurgia maggiore nei 21 giorni precedenti l’ingresso in studio
7) Anamnesi di altre neoplasie maligne (eccetto carcinoma basocellulare o carcinoma cervicale in situ, adeguatamente trattato), a meno che non sia in remissione da 5 anni o più e giudicato essere a potenziale trascurabile di ricaduta
8) Donne in gravidanza o in allattamento
9) Malattia cardiovascolare con NYHA status >2. Storia di infarto miocardico meno di 6 mesi prima dell’inizio del trattamento. Sono esclusi i pazienti con angina instabile e con aritmia severa che pone a rischio la vita.
10) Soggetti a rischio per la sindrome del QT allungato o un prolungamento dell’intervallo QTc = 501 msec in almeno 2 distinti ECG effettuato dopo la correzione dello sbilancio elettrolitico.
11) Storia medica di eventi trombotici arteriosi o embolici quali infarto cerebro-vascolare (compreso l’attacco ischemico transiente – TIA) o embolia polmonare nei 6 mesi precedenti l’inizio del trattamento di studio
12) Storia nota di infezione da virus HIV
13) Epatite B o C attiva o cronica che richiede il trattamento con farmaci antivirali
14) Storia clinica di emorragia o sanguinamenti di grado = 3 (secondo NCI CTCAE v 5.0) nelle 4 settimane precedenti l’inizio del trattamento in studio
15) Evidenza di ogni grave o instabile malattia o condizione medica, psicologica, o sociale che possa geopardizzare la sicurezza del paziente e/o la sua compliance alla partecipazione allo studio o alla valutazione dei risultati
16) Ipersensibilità nota al farmaco in studio, o alla sua classe di appartenenza o ad eccipienti presenti nella formulazione dei farmaci in studio
17) Pazienti in cui la tossicità acuta delle precedenti terapie anti-tumorali non è risolta a grado = 1secondo i criteri CTCAE, con eccezione della neuropatia periferica (vedi criterio di esclusione nr 18) ed alopecia
18) Neuropatia periferica pre-esistente > di grado 2 secondo i criteri CTCAE
19) Ogni situazione che possa pregiudicare la compliance al trattamento
20) Soggetti con metastasi note a livello del Sistema Nervoso Centrale

E.5 End points

E.5.1

Primary end point(s)

Overall tumor Response Rate, according to RECIST v 1.1 : Portion of patients with a tumor size reduction according RECIST

Tasso di risposta tumorale (Overall Tumor Response Rate) secondo i criteri RECIST 1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluated from the time of initial response until documented tumor progression.

Valutata dal momento della risposta inziale fino a PD documentata

E.5.2

Secondary end point(s)

1. Choi Response Rate
2. Overall Survival (OS)
3. Progression Free Survival (PFS)
4. Clinical Benefit Rate
5. Duration of response
6. Safety

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Evaluated from the time of initial response until documented tumor progression according Choi Criteria
2)Evaluated from the time of trial entrance to death for any cause (at 3 and 5 years)
3)Evaluated from the time of treatment start to the first documented PD (every 6 weeks)
4) Evaluated from the time of treatment start to its end (every 3 weeks)
5) Evaluated from the time of the first response to progression (every 6 weeks)
6) Evaluated from the time of treatment start to its end (every 3 weeks)

1) Valutata dal momento della risposta inziale fino a PD documentata secondo i criteri Choi
2) Valutata dal momento dell'ingresso in studio al decesso per ogni causa (a 3 e a 5 anni)
3) Valutata dell'inizio trattamento alla prima progresione documentata (ogni 6 settimane)
4) Valutata dell'inizio trattamento fino alla sua fine (ogni 3 settimane)
5) Valutata dalla prima risposta fino a progressione di malattia (ogni 6 settimane)
6) Valutata dell'inizio trattamento fino alla sua fine (ogni 3 settimane)

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

E.6.6

Pharmacokinetic

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

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

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.8.6 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.1.1.1

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)

Patient will be treated according the ESMO and AIOM disease guidelines

I pazienti verranno trattati secondo le linee guida di patologia AIOM ed ESMO

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

2019-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-28

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

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