Clinical Trials Register

Summary
EudraCT Number:	2022-004188-25
Sponsor's Protocol Code Number:	ASST_FARM_ONCO_P-ACC_2022
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:	2023-01-10
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

2022-004188-25

A.3

Full title of the trial

P-ACC Trial - Phase II, single arm, multicenter, open-label study of PARP inhibitors + cisplatin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

P-ACC Trial: Studio di fase II; singolo braccio, multicentrico, in aperto, che valuta la combinazione PARP inibitore + cisplatino in pazienti affetti da carcinoma adenoide cistico recidivo e/o metastatico

A.3.1

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

Phase II, single arm, multicenter, open-label study of PARP inhibitors + cisplatin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

Studio di fase II; singolo braccio, multicentrico, in aperto, che valuta la combinazione PARP inibitore + cisplatino in pazienti affetti da carcinoma adenoide cistico recidivo e/o metastatico

A.3.2

Name or abbreviated title of the trial where available

P-ACC INDAGA

A.4.1

Sponsor's protocol code number

ASST_FARM_ONCO_P-ACC_2022

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	AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
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	FFRB _REGIONE LOMBARDIA
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	ASST DEGLI SPEDALI CIVILI DI BRESCIA
B.5.2	Functional name of contact point	PROGETTAZIONE RICERCA E STUDI DI F1
B.5.3	Address:
B.5.3.1	Street Address	P.LE SPEDALI CIVILI
B.5.3.2	Town/ city	BRESCIA
B.5.3.3	Post code	25123
B.5.3.4	Country	Italy
B.5.4	Telephone number	0303996851
B.5.6	E-mail	coordinamento.ricerca@asst-spedalicivili.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.2.1.2	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	cisplatino
D.3.2	Product code	[cisplatino]
D.3.4	Pharmaceutical form	Concentrate for solution for injection/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	CISPLATINO
D.3.9.2	Current sponsor code	cisplatino
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	70
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.IMP: 2
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	ZEJULA - 100 MG - CAPSULA RIGIDA - USO ORALE - BLISTER (PCTFE/PVC/ALU) - 84 X 1 CAPSULE (DOSE UNITARIA)
D.2.1.1.2	Name of the Marketing Authorisation holder	TESARO BIO NETHERLANDS B.V.
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	zejula
D.3.2	Product code	[zeluja]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Yes
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	NIRAPARIB
D.3.9.2	Current sponsor code	NIRAPARIB
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	100
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

patients with recurrent and/or Metastatic Adenoid Cystic Carcinoma

pazienti affetti da carcinoma adenoide cistico recidivo e/o metastatico

E.1.1.1

Medical condition in easily understood language

patients with recurrent and/or Metastatic Adenoid Cystic Carcinoma

pazienti affetti da carcinoma adenoide cistico recidivo e/o metastatico

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	10053231
E.1.2	Term	Adenoid cystic carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10073370
E.1.2	Term	Adenoid cystic carcinoma of salivary gland
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10053231
E.1.2	Term	Adenoid cystic carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.1
E.1.2	Level	LLT
E.1.2	Classification code	10085951
E.1.2	Term	Adenoid cystic carcinoma metastatic
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

evaluate activity of the PARPi niraparib in combination with cisplatin

valutare l’attività della combinazione PARPi + cisplatino

E.2.2

Secondary objectives of the trial

Overall Survival assessed according to RECIST 1.1
Progression Free Survival assessed according to RECIST 1.1
Safety assessed according to CTCAE 5.0
QoL assessed by QoL QLQ HN43 and C30 questionnairecurativo standard. Diagnosi di recidiva a meno di 6 mesi dall’inizio del trattamento sperimentale previsto;
- Recidiva a distanza o ACC metastatico ab initio non candidabile a trattamento curativo standard. Diagnosi di recidiva a distanza a meno di 6 mesi dall’inizio del trattamento sperimentale previsto;
- Pregresso trattamento con terapia target e/o chemioterapia è permesso se effettuato almeno 4 settimane prima dell'avvio del trattamento sperimentale previsto;

Overall Survival (OS) valutata tramite RECIST 1.1
Progression Free Survival (PFS) valutata tramite RECIST 1.1
Tolleranza valutata tramite CTCAE 5.0
Quality of Life (QoL) valutata tramite i questionari QoL QLQ HN43 / C30

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age = 18 years;
- Signature Informed Consent;
- Histological diagnosis of ACC;Primary ACC not amenable of curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to irradiate for any reason);
- Locoregional recurrent ACC not amenable to curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to re-irradiate for any reason) with a history of clinical or symptomatic disease progression within 6 months;
- Metastatic ACC (distant spread) not amenable to surgical therapy or radiotherapy and with a history of clinical or symptomatic disease progression within 6 months;
- Prior treatment with targeted therapy and/or chemotherapy is allowed if performed more than 4 weeks since protocol start:
- ECOG PS of 0-1; - Adequate hematologic and organ functions

Età = 18 anni; - Acquisizione Consenso Informato;
Diagnosi istologica di ACC;
ACC primario non candidabile a trattamenti curativi da standard of care (ad esempio tumori non resecabili chirurgicamente o lesioni non candidabili a radioterapia per qualunque motivo);
Recidiva locoregionale di ACC non candidabile a trattamento
Condizioni cliniche adeguate (PS ECOG = 0-1), funzionalità ematologica, renale ed epatica nei limiti.

E.4

Principal exclusion criteria

History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent;
Previous treatment with PARPi;
Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases;
Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy;
Medical conditions that might interfere with study treatment;
Women must not be pregnant or breastfeeding; pregnant women are excluded from this study.

Anamnesi di reazione allergica severe o anafilattiche o ipersensibilità ad uno o più componenti del trattamento sperimentale;
- Pregresso trattamento con PARPi;
- Metastasi nel sistema nervoso centrale o a livello leptomeningeo sintomatiche o non sotto controllo;
- Non recupero a tossicità G < 1 dal precedente trattamento chemioterapico, radioterapico, biologico, immunoterapico o sperimentale;
- Comorbidità che possano interferire col trattamento
- Le donne non devono essere gravide o in corso di allattamento.

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate (ORR) assessed according to RECIST 1.1

Overall Response Rate (ORR) valutata tramite RECIST 1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

every time to followup

ad ogni punto di followup

E.5.2

Secondary end point(s)

Overall Survival assessed according to RECIST 1.1
Progression Free Survival assessed according to RECIST 1.1
Safety assessed according to CTCAE 5.0
QoL assessed by QoL QLQ HN43 and C30 questionnaire

E.5.2.1

Timepoint(s) of evaluation of this end point

every time to followup

ad ogni punto del followup

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

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

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)

National Health System

Sistema Sanitario Nazionale

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

2023-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-10

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

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