Clinical Trials Register

Summary
EudraCT Number:	2012-002046-20
Sponsor's Protocol Code Number:	IOVHN12012
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:	2012-07-23
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

2012-002046-20

A.3

Full title of the trial

Role of SAMITAL in prevention and treatment of oral mucositis in patients treated with chemo-radiation (CT/RT)for head-and-neck squamous cell carcinomas. A double-blind, Phase 2 placebo controlled, randomized trial.

Ruolo di SAMITAL nella prevenzione e cura della mucosite orale in pazienti con carcinoma squamoso del distretto testa-collo trattati con chemio-radioterapia (CT-RT). Studio clinico di Fase 2, randomizzato, in doppio cieco con impiego di placebo.

A.3.1

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

Role of SAMITAL in the relief of chemo-radiation (CT-RT) induced oral mucositis in head and neck cancer patients. A Phase II placebo controlled randomised trial.

Ruolo di SAMITAL nella prevenzione e cura della mucosite orale indotta da chemio-radioterapia, in pazienti con tumore del distretto testa-collo. Studio di Fase II, randomizzato, controllato con placebo.

A.3.2

Name or abbreviated title of the trial where available

IOV-HN-1-2012 (ROSAM)

A.4.1

Sponsor's protocol code number

IOVHN12012

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	ISTITUTO ONCOLOGICO VENETO
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	Indena S.p.A.
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	Istituto Oncologico Veneto
B.5.2	Functional name of contact point	Sperim. Cliniche e Biostatistica
B.5.3	Address:
B.5.3.1	Street Address	Via Gattamelata 64
B.5.3.2	Town/ city	Padova
B.5.3.3	Post code	35128
B.5.3.4	Country	Italy
B.5.4	Telephone number	049/8215704-5710
B.5.5	Fax number	049/8215706
B.5.6	E-mail	gianluca.desalvo@unipd.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	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	SAMITAL
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Granules for oral suspension
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	VACCINIUM MYRTILLUS
D.3.9.1	CAS number	8001000-49-5
D.3.9.4	EV Substance Code	SUB15678MIG
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Macleaya cordata
D.3.9.3	Other descriptive name	Macleaya cordata alcaloidi 70%
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	2.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ECHINACEA ANGUSTIFOLIA
D.3.9.1	CAS number	8001000-31-5
D.3.9.4	EV Substance Code	SUB13657MIG
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	.6
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Granules for oral suspension
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Head-and-neck cancer (Squamous cell carcinomas)

Carcinoma squamoso del distretto testa-collo

E.1.1.1

Medical condition in easily understood language

Head and neck cancer

Tumore del distretto testa-collo

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing to chemo-radiotherapy.

Verificare l’attività di SAMITAL nel ridurre l’incidenza di mucosite severa in pazienti con carcinoma del distretto testa-collo sottoposti a chemio-radioterapia.

E.2.2

Secondary objectives of the trial

Assess tolerability of SAMITAL and the impact on patients reported outcomes.

Valutare la tollerabilità di SAMITAL ed il suo impatto sulla qualità di vita e sui sintomi riportati dai pazienti.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Histologically proven squamous cell carcinomas of the head-and-neck; •primary tumor sites eligible: oral cavity, oropharynx, larynx, hypopharynx; •stage III or IV disease without evidence of distant metastases; •patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemoradiotherapy; •age 18-75 years; •Karnofsky Performance Status ≥70; •life expectancy ≥6 months; able to swallow and retain oral medication; •good state of dentation; •patients must be available for treatment and follow-up; •insurance by the patient and/or partner who will use adequate contraception; •signed informed consent

•Diagnosi istologica di carcinoma squamoso del distretto testa-collo; •Sedi di tumore primario eleggibili: cavità orale, orofaringe, laringe, ipofaringe; •Stadio III o IV di malattia senza evidenza di metastasi a distanza; •Pazienti candidati a chemio-radioterapia concomitante o chemioterapia di induzione seguita da chemio-radioterapia; •Età compresa tra 18 e 75 anni; •Karnofsky Performance Status ≥ 70; •Spettanza di vita ≥ 6 mesi; •Capacità di assumere il farmaco in studio secondo le modalità previste; •Stato di dentizione buono o recentemente sottoposto a bonifica; •Disponibilità di sottoporsi a follow-up; • Assicurazione da parte del paziente e/o partner che verranno utilizzati adeguati metodi contraccettivi; •Consenso informato scritto.

E.4

Principal exclusion criteria

•Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx; •seroius comorbidities: uncontrolled heart disease, heart failure within 6 months prior to study partecipation, history of serious neurological and/or psychiatric abnormality; •chronic administration of steroids or immunosuppressant; •pregnant female.

•Precedente irradiazione delle mucose del cavo orale e/o dell’orofaringe, laringe, ipofaringe; •Significative comorbidità: - patologie cardiache non controllate farmacologicamente; - infarto del miocardio nei 6 mesi precedenti la partecipazione allo studio; - anamnesi positiva per gravi disordini neurologici o psichiatrici; •Uso cronico di farmaci steroidi o immunosoppressori; •Donne in gravidanza.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developed at any time during the whole study period.

Proporzione di soggetti con grado III, IV di mucosite misurata con la WHO mucositis scale, sviluppata in qualsiasi momento, durante tutto il periodo di studio.

E.5.1.1

Timepoint(s) of evaluation of this end point

Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy.

Settimanalmente durante la radioterapia, a 4 settimane e a 3 mesi dalla fine della radioterapia

E.5.2

Secondary end point(s)

•Incidence of adverse events assessed by NCI-CTCAE version 4.0; •Days of CT-RT treatment interruption and their period suspection; •Use of enteral or parenteral nutritional support; •Weight loss; •Use of analgesic drugs during CT-RT; •Changes of the Karnofsky Performance Status at the 11th week; •Quality of life assessed by EORTC QLQ-C30 and QLQ-H&N35; •Grade of Xerostomia and its trend over time assessed by Xerostomia Questionnaire.

•Incidenza di eventi avversi valutata con la NCI-CTCAE v.4 ; •Interruzione/i del trattamento chemio-radioterapico e relativa durata in giorni della sospensione; •Ricorso a supporto nutrizionale artificiale enterale o parenterale; •Calo ponderale; •Impiego e categoria dei farmaci analgesici utilizzati durante la chemio-radioterapia; •Modificazione del Karnofsky Performance Status all’undicesima settimana •Qualità della Vita valutata con i questionari EORTC QLQ-C30 e QLQ-H&N35; •Grado di xerostomia e suo andamento temporale valutato con Xerostomia Questionnaire

E.5.2.1

Timepoint(s) of evaluation of this end point

Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. For the quality of life, at 4th, 7th, 11th and 23rd weeks.

Settimanalmente durante la radioterapia, a 4 settimane e a 3 mesi dalla fine della radioterapia. Per la qualità della vita, a 4, 7, 11 e 23 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

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

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

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.8.6 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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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:

100

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

120

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)

Standard clinical practice

Normale pratica 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

2012-05-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-28

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

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