Clinical Trials Register

Summary
EudraCT Number:	2018-000655-40
Sponsor's Protocol Code Number:	ACAPP
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:	2021-06-08
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

2018-000655-40

A.3

Full title of the trial

ADJUVANT CAPECITABINE IN HIGH RISK PSEUDOMYXOMA PERITONEI PATIENTS TREATED WITH CYTOREDUCTIVE SURGERY (CRS) AND HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)

CAPECITABINA ADIUVANTE NEI PAZIENTI TRATTATI CON CHIRURGIA CITORIDUTTIVA (CRS) E CHEMIOTERAPIA INTRAPERITONEALE IPERTERMICA (HIPEC) PER PSEUDOMYXOMA PERITONEI AD ALTO RISCHIO DI RECIDIVA

A.3.1

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

Adjuvant capecitabine in patients with early diagnosis of pseudomyxoma peritonei (PMP), who underwent cytoreductive surgery (CRS) and intraperitoneal hyperthermic chemotherapy (HIPEC).

Capecitabina adiuvante nei pazienti con prima diagnosi di pseudomyxoma peritonei (PMP), sottoposti a chirurgia citoriduttiva (CRS) e chemioterapia ipertermica intraperitoneale (HIPEC).

A.3.2

Name or abbreviated title of the trial where available

ACAPP

A.4.1

Sponsor's protocol code number

ACAPP

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.5.4

Other Identifiers

Name:

ACAPP

Number:

ADJUVANT CAPECITABINE PSEUDOMYXOMA PERITONEI

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 IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
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	AIRC
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	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
B.5.2	Functional name of contact point	Clinical Trial Center
B.5.3	Address:
B.5.3.1	Street Address	via G. Venezian, 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	02/23903818
B.5.5	Fax number	02/23903991
B.5.6	E-mail	trialcenter@istitutotumori.mi.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	CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120X1 COMPRESSE (DOSE UNITARIA)
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
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	Capecitabina
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	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITABINA
D.3.9.1	CAS number	154361-50-9
D.3.9.2	Current sponsor code	Capecitabina
D.3.9.3	Other descriptive name	Capecitabine
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	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

PMP PSEUDOMYXOMA PERITONEI

E.1.1.1

Medical condition in easily understood language

PMP PSEUDOMYXOMA PERITONEI, characterized by mucinous tumors in the abdomen and in the pelvis

PMP Pseudomyxoma del peritoneo,caratterizzato da tumori mucinosi nell'Addome e nel Bacino

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10061269
E.1.2	Term	Malignant peritoneal neoplasm
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 postoperative capecitabine in terms of progression free survival (PFS) after Cytoreduction CRS and HIPEC in PMP patients with KRAS mutated .

Valutare l¿efficacia, in termini di sopravvivenza libera da progressione (PFS), della capecitabina adiuvante nei pazienti affetti da Pseudomyxoma Peritonei (PMP) con presenza di mutazione del gene KRAS e sottoposti a CRS e HIPEC.

E.2.2

Secondary objectives of the trial

1.To assess the efficacy of adjuvant capecitabine treatment in terms of overall survival (OS) and disease specific survival (DSS).
2.To evaluate the feasibility and safety of the capecitabine administered in patients previously treated with CRS and HIPEC

1.Valutare l¿efficacia della capecitabina adiuvante in termini di sopravvivenza globale (OS) e sopravvivenza malattia specifica (DSS).
2.Valutare la fattibilit¿ e la tollerabilit¿ del trattamento con capecitabina somministrata a pazienti precedentemente sottoposti a CRS e HIPEC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histological diagnosis of pseudomyxoma peritonei (PMP)
2.Assessment of KRAS mutation on surgical sample
3. Patients submitted to a complete cytoreductive surgery and HIPEC for PMP
4. Age >= 18 years and <76 years
5.Performance Status (ECOG <2)
6.Adequate organ function including the following:
Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL
Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
Renal: Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL
7. Patients compliance and geographic proximity that allows for adequate follow-up
8. Patients must sign an informed consent document (ICD)
9. Male and female patients with reproductive potential must use an approved contraceptive method.

1.diagnosi istologica di pseudomyxoma peritonei (PMP)
2.diagnosi di mutazione del gene KRAS.
3.pazienti sottoposti a Chirurgia di citoriduzione completa e chemioipertermia intraperitoneale (HIPEC).
4. Età >= 18 anni e <76 anni
5.Performance Status (ECOG) < 2
6.Buona riserva funzionale degli organi valutata secondo i seguenti parametri:
leucociti >3.0x109/L, neutrofili >1.5x109/L, piastrini >100x109/L, e emoglobina >10 g/dL.
Enzime epatiche: bilirubina < 1.5 volte il limite superiore del valore di riferimento (ULN), fosfatasi alcalina, ALT e AST < 2.5 x ULN.
Creatinine clearance >50 mL/min o creatinina sierica 1.5 x ULN.
7.Una adeguata compliance del paziente e prossimità geografica che consenta un follow-up consistente.
8.Firma del consenso informato
9. I pazienti in età riproduttiva devono utilizzare metodi contraccettivi approvati.

E.4

Principal exclusion criteria

1.Previous systemic chemotherapy and/or biological therapy
2.Administration of other experimental drugs during the study
3.Pregnancy and breast-feeding
4. Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment
5.Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis
6.Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures
7. Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years

1.chemioterapia o terapia biologica previa;
2. somministrazione di altri terapie oncologiche sperimentali durante il periodo dello studio;
3. gravidanza o allattamento;
4. comorbilità severa o infezioni attive che possano compromettere la continuità del trattamento in studio;
5.condizioni che possano compromettere l’assorbimento della capecitabina come l’occlusione intestinale, morbo di Crohn o colite ulcerativa;
6. malattie psichiatrica, neurologica o di altra natura che possano impossibilitare le procedure previste dal protocollo;
7. anamnesi positiva per altre patologie neoplastiche eccetti i casi controllati senza evidenza di recidiva da più di cinque anni.

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS)

Sopravvivenza libera da Progressione (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS will be measured from the date of randomization to the date of radiological / clinical progression of the disease or death (depending on what occurs first)

La PFS sarà misurata dalla data di randomizzazione alla data di progressione radiologica/clinica della malattia o alla morte ( a seconda di ciò che si verifica prima)

E.5.2

Secondary end point(s)

Overall Survival

Sopravvivenza Globale

E.5.2.1

Timepoint(s) of evaluation of this end point

Overall Survival will be measured from the date of randomization to the date of death

La Sopravvivenza globale sar¿ misurata dalla data di randomizzazione alla data di morte

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

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Intervento chirurgico di chirurgia citoriduttiva (CRS), associato a infusione di chemioterapia iper

Cytoreductive surgery (CRS), associated with intraperitoneal hyperthermic chemotherapy infusion (HI

E.8.2.4

Number of treatment arms in the trial

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

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)

At the end of the treatment the patients will be in a follow-up period of 2 years

Al termine del trattamento i pazienti entreranno in un periodo di Follow Up della durata di 2 anni

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

2018-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-20

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

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