Clinical Trials Register

Summary
EudraCT Number:	2009-016940-38
Sponsor's Protocol Code Number:	REO018
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:	2012-09-27
Trial results	View 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

2009-016940-38

A.3

Full title of the trial

Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination with Paclitaxel and Carboplatin versus the Chemotherapy Alone in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck who have Progressed on or after Prior Platinum-Based Chemotherapy.

Studio randomizzato, in doppio cieco, multicentrico, di fase 3, condotto sulla somministrazione per endovena di REOLYSIN (Reovirus tipo 3 Dearing) in combinazione con Paclitaxel e Carboplatino vs. la sola chemioterapia in pazienti affetti da carcinoma a cellule squamose della testa-collo metastatico o recidivante, con progressione durante o dopo chemioterapia a base di platino.

A.3.1

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

Studio randomizzato, in doppio cieco, multicentrico a due stadi, di fase adattiva 3, condotto sulla somministrazione per endovena di REOLYSIN(Reovirus tipo 3 Dearing) in combinazione con Paclitaxel e Carboplatino vs. la sola chemioterapia in pazienti affetti da carcinoma a cellule squamose della testa-collo metastatico o recidivante, con progressione durante o dopo precedente chemioterapia a base di platino.

A.4.1

Sponsor's protocol code number

REO018

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	ONCOLYTICS
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Oncolytics Biotech Inc.
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Oncolytics Biotech Inc.
B.5.2	Functional name of contact point	Informazione Sperimentazione
B.5.3	Address:
B.5.3.1	Street Address	Via Ghibellina 81
B.5.3.2	Town/ city	Firenze
B.5.3.3	Post code	50122
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39-055-6286376
B.5.5	Fax number	+39-055-5001650
B.5.6	E-mail	giacomo.spignoli-UNB@gaea.co.uk

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	Reolysin
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Concentrate for 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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	Reolysin
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30000000000
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	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	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Reovirus type 3 Darling
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Carbo-Cell
D.2.1.1.2	Name of the Marketing Authorisation holder	Cell Pharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Concentrate 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	CARBOPLATIN
D.3.9.1	CAS number	41575-94-4
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/h milligram(s)/hour
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5
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	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Celltaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Cell Pharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Concentrate 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB09583MIG
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	175
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	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

Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.

Carcinoma a cellule squamose della testa-collo metastatico o recidivante.

E.1.1.1

Medical condition in easily understood language

Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.

Carcinoma a cellule squamose della testa-collo metastatico o recidivante.

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	15.0
E.1.2	Level	PT
E.1.2	Classification code	10063569
E.1.2	Term	Metastatic squamous cell carcinoma
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

Compare overall survival for the two different treatments in the study (chemotherapy + Reolysin vs. chemotherapy alone).

Confronto della sopravvivenza complessiva per i due differenti trattamenti in studio (chemioterapia + Reolysin vs. sola chemioterapia.

E.2.2

Secondary objectives of the trial

1. Compare progression free survival for the treatment regimens in the study population. 2. Compare Objective Response (Complete Response (CR) + Partial Response (PR)) rate and duration of response for the treatment regimens in the study population. 3. Compare the safety and tolerability of the treatment regimens in the study population.

1. Confronto della sopravvivenza senza progressione per i regimi di trattamento nella popolazione dello studio. 2. Confronto del tasso di risposta obiettiva (risposta completa (CR) + risposta parziale (PR)) e durata della risposta per i regimi di trattamento nella popolazione dello studio. 3. Confronto di sicurezza e tollerabilità dei regimi di trattamento nella popolazione dello studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers. Note: Patients with NPC without distal metastasis(es) or with undifferentiated NPC are NOT eligible. 2. Have at least one lesion that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI). (Lesions persisting in previously treated radiation fields are considered NOT evaluable for response. Lesions in previous radiation fields are considered evaluable for response if representing a relapse in a mucosal or nodal lesion that previously demonstrated a complete response. Any new lesion within the previous radiation fields is acceptable for determination of response and/or progression). 3. Have completed first line chemotherapy for R/M SCCHN which progressed on or within 190 days following the completion of platinum or platinum-based chemotherapy (including platinum/cetuximab regimens if approved and/or available for the patient).

1. essere affetto/a da carcinoma della testa-collo (orofaringe, cavità orale, laringe, ipofaringe) a cellule squamose (SCC) recidivante o metastatico (R/M) istologicamente confermato, o da carcinoma rinofaringeo (nasopharynx cancer, NPC) a cellule squamose con metastasi distale/i e senza cancri secondari. 2. Almeno una lesione misurabile tramite tomografia computerizzata (TC) o imaging a risonanza magnetica (magnetic resonance imaging, MRI). (Le lesioni persistenti in campi di irradiazione precedentemente trattati NON sono considerate valutabili per la risposta. Le lesioni in precedenti campi di irradiazione sono considerate valutabili per la risposta se rappresentano una recidiva in una lesione della mucosa o in una lesione nodulare che aveva precedentemente evidenziato un risposta completa. Qualsiasi nuova lesione localizzata entro il precedente raggio di irradiazione è accettabile per determinare la risposta e/o la progressione). 3. Una chemioterapia completa di prima linea per R/M SCCHN con progressione in chemioterapia o entro 190 giorni in seguito al completamento di una chemioterapia a base di platino (compresi i regimi a base di platino/cetuximab se approvati e/o disponibili per il/la paziente).

E.4

Principal exclusion criteria

1. Receive concurrent therapy with any other investigational anticancer agent while on study. 2. Have been treated with a taxane for SCCHN. 3. Have current -- or with a history of -- brain metastases because of their poor prognosis and because of the frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

1. Ricevere una terapia concomitante con qualsiasi altro agente oncologico sperimentale durante lo studio. 2. Essere stato/a trattato/a con un taxano per l'SCCHN. 3. Evidenziare attualmente - o nell'anamnesi - metastasi cerebrali associate a prognosi inadeguata e al frequente sviluppo di disfunzione neurologica progressiva, che confonderebbe la valutazione di eventi avversi neurologici e di altra natura.

E.5 End points

E.5.1

Primary end point(s)

Overall survival for the treatment regimens in the study population.

Sopravvivenza complessiva per i regimi di trattamento nella popolazione dello studio.

E.5.1.1

Timepoint(s) of evaluation of this end point

CT with contrast or MRI covering head and neck, lung and liver fields are required for all patients and will be collected for central review by an independent radiology review committee as further described in the study manual and a separate imaging charter. The tumors will be assessed following the revised RECIST Guidelines version 1.1 (Eisenhauer et al., 2009). Evaluation of tumor status will be conducted at baseline, at the end of week 6 on study and then every 6 weeks on and after study until disease progression, study termination, initiation of subsequent anticancer therapy, death, loss to follow-up or withdrawal of consent.

I pazienti verranno valutati tramite TC o MRI seguendo le linee guida revisionate RECIST, versione 1.1 (Eisenhauer et al., 2009). La valutazione dello stato tumorale sarà condotta al basale, alla fine della settimana di studio 6 e, successivamente, ogni 6 settimane durante e dopo lo studio fino a che si verifichi uno dei seguenti eventi: progressione della malattia, termine dello studio, inizio di una successiva terapia oncologica, decesso, perdita al follow up o ritiro del consenso.

E.5.2

Secondary end point(s)

(1) Compare progression free survival for the treatment regimens in the study population. (2) Compare Objective Response (Complete Response (CR) + Partial Response (PR)) rate and duration of response for the treatment regimens in the study population. (3) Compare the safety and tolerability of the treatment regimens in the study population.

(1) Confronto della sopravvivenza senza progressione per i regimi di trattamento nella popolazione dello studio. (2) Confronto del tasso di risposta obiettiva (risposta completa (CR) + risposta parziale (PR)) e durata della risposta per i regimi di trattamento nella popolazione dello studio. (3) Confronto di sicurezza e tollerabilità dei regimi di trattamento nella popolazione dello studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

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

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:

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

240

F.4.2.2

In the whole clinical trial

480

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)

The patients will receive the best available therapy and care.

I pazienti riceveranno il miglior trattamento e la migliore assistenza disponibile.

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

2011-09-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-19

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

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