Clinical Trials Register

Summary
EudraCT Number:	2015-002411-14
Sponsor's Protocol Code Number:	12576/15
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:	2020-11-04
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

2015-002411-14

A.3

Full title of the trial

TRABECTEDIN SINGLE AGENT IN PARTIALLY PLATINUM SENSITIVE (PPS) RECURRENT OVARIAN CANCER (ROC) PATIENTS: A PROSPECTIVE, PHASE II STUDY

Trabectedina in monoterapia in pazienti affette da recidiva di carcinoma ovarico parzialmente platino-sensibili: studio prospettico di fase II.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

12576/15

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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	PHARMAMAR 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	POLICLINICO GEMELLI
B.5.2	Functional name of contact point	UOC GINECOLOGIA ONCOLOGICA
B.5.3	Address:
B.5.3.1	Street Address	L.GO A GEMELLI 8
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630158545
B.5.5	Fax number	0630157241
B.5.6	E-mail	clinicaltrials@rm.unicatt.it

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	YONDELIS - 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	PHARMA MAR S.A.
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	Yondelis
D.3.4	Pharmaceutical form	Powder 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	TRABECTEDINA
D.3.9.2	Current sponsor code	nd
D.3.9.3	Other descriptive name	nd
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	1
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	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

ovarian cancer

carcinoma ovarico

E.1.1.1

Medical condition in easily understood language

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	10051938
E.1.2	Term	Ovarian adenocarcinoma
E.1.2	System Organ Class	100000004864

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

Evaluation of efficacy of single agent trabectedin in first line treatment in partially platinum-senstive recurrent ovarian cancer.

valutazione dell'efficacia della trabectedina in monoterapia nel trattamento di prima linea nel trattamento del carcinoma ovarico parzialmente platino sensibile.

E.2.2

Secondary objectives of the trial

Duration of response
¿ Progression-free survival
¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire.

Durata della risposta
¿ Progression-free survival
¿ Profilo di sicurezza di trabectedina e valutazione della qualit¿ di vita and (QoL) con il questionario EORTC-OV-28.

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: MECHANISMS OF ACTION OF TRABECTEDIN IN OVARIAN CANCER

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Meccanismo di azione della trabectedina in tumori ovarici

E.3

Principal inclusion criteria

1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have not received first line treatment.
2. 18 years of age of older
3. Patient’s written informed consent before any clinical trial specific procedures
4. Measurable disease according to RECIST criteria
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
6. Hematologic variables:
• Hemoglobin = 9 g/dL
• Absolute Neutrophils count (ANC) =1,500/µL
• Platelets count =100,000/µL
• Serum Creatinine = 1.5 mg/dL or Creatinine Clearance = 30 mL/min
• Creatinine Phosphokinase (CPK) = 2.5 ULN
• Hepatic function variables
• Total Bilirubin = ULN.
• Total Alkaline Phosphatase = 2.5 ULN
• AST (serum aspartate transaminase [SGOT]) must be = 2.5 x ULN
• ALT (serum alanine transaminase [SGPT]) must be = 2.5 x ULN
• Albumin = 25 g/l.
7. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower

1. Pazienti affette da prima recidiva di carcinoma ovarico parzialmente platino-sensibili (intervallo libero da platino 6-12 mesi).
2. Età = 18 anni
3. Consenso informato scritto della paziente prima di qualsiasi procedura specifica dello studio
4. Malattia misurabile secondo criteri RECIST.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) pari a 0-1
6. Variabili ematologiche:
• Emoglobina = 9 g/dL
• Conta assoluta dei neutrofii (ANC) =1,500/µL
• Conta piastrinica =100,000/µL
• Creatinina = 1.5 mg/dL or Creatinina Clearance = 30 mL/min
• Creatinin Fosfochinasi (CPK) = 2.5 ULN
7. Variabili di funzionalità epatica:
• Bilirubina totale = ULN.
• Fosfatasi alcalina = 2.5 ULN
• AST (SGOT) = 2.5 x ULN
• ALT (SGPT) = 2.5 x ULN
• Albumina = 25 g/l.
8. Recupero da tossicità di precedent trattamenti al Grado 1 o normalità in accordo al NCI CTCAE.

E.4

Principal exclusion criteria

1. Prior exposure to trabectedin
2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
3. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
4. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
5. Known clinically relevant CNS metastases
6. Other serious illnesses, such as: congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias.
7. Psychiatric disorder that prevents compliance with protocol.
8. Active viral hepatitis; or chronic liver disease.
9. Active infection.
10. Any other unstable medical conditions.

1. Precedente trattamento con trabectedina
2. Accertata ipersensibilità a qualsiasi componente della formulazione endovena di trabectedina o desametasone.
3. Meno di 4 settimane dall’ultima dose di terapia con qualsiasi altro farmaco in studio o chemioterapico.
4. Storia di alter malattie neoplastiche negli ultimi tre anni (eccetto carcinoma cutaneo basocellulare o carcinoma della cervice uterine in sede adeguatamente trattato)
5. Presenza accertata di metastasi cerebrali.
6. Altre malattie serie: scompenso cardiaco o angina pectoris; infarto del miocardio nell’anno precedente l’arruolamento nello studio; ipertensione arteriosa non controllata farmacologicamente o aritmie.
7. Malattie psichiatriche che possano pregiudicare la compliance al trattamento in studio.
8. Epatiti virali attive o malattie epatiche croniche.
9. Infezioni attive.
10. Qualsiasi altra instabile condizione medica.

E.5 End points

E.5.1

Primary end point(s)

evaluation of objective response rate to trabectedin by Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1) in recurrent partially platinum sensitive ovarian cancer patients

valutazione del tasso di risposte obiettive secondo criteri RECIST (Response Evaluation Criteria in Solid Tumor (versione 1.1) in paziente affette da recidive di carcinoma ovarico parzialmente platino-sensibili.

E.5.1.1

Timepoint(s) of evaluation of this end point

36 months

36 mesi

E.5.2

Secondary end point(s)

Duration of response
¿ Progression-free survival
¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire.

Durata della risposta
¿ Progression-free survival
¿ Profilo di sicurezza di trabectedina e valutazione della qualit¿ di vita and (QoL) con il questionario EORTC-OV-28.

E.5.2.1

Timepoint(s) of evaluation of this end point

36 mesi

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

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

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.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

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)

clinical practice

routine clinica

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

2015-07-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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