Clinical Trials Register

Summary
EudraCT Number:	2018-004242-42
Sponsor's Protocol Code Number:	J1S-MC-JV01
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:	2021-06-18
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

2018-004242-42

A.3

Full title of the trial

A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor.

Studio di Fase 1/2, randomizzato, in aperto per la valutazione di Ramucirumab in pazienti pediatrici e giovani adulti con Tumore Desmoplastico a Piccole Cellule Rotonde in forma recidivante, ricorrente o refrattaria

A.3.1

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

A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.

Studio per valutare Ramucirumab in bambini e giovani adulti con Tumore Desmoplastico a Piccole Cellule Rotonde

A.3.2

Name or abbreviated title of the trial where available

J1S-MC-JV01

CAMPFIRE

A.4.1

Sponsor's protocol code number

J1S-MC-JV01

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center , DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.com

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	Cyramza 10 mg/ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Ramucirumab
D.3.2	Product code	[LY3009806]
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	Ramucirumab
D.3.9.1	CAS number	947687-13-0
D.3.9.2	Current sponsor code	LY3009806
D.3.9.3	Other descriptive name	Cyramza
D.3.9.4	EV Substance Code	SUB32795
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Yes
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	Endoxan
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Oncology 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.3.1	Product name	Ciclofosfamide
D.3.2	Product code	[Ciclofosfamide]
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	CICLOFOSFAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	Ciclofosfamide
D.3.9.4	EV Substance Code	SUB06859MIG
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	50
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: 3
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	Vinorelbin Aurobindo 10 mg/ml Konzentrat zur Herstellung einer Infusionslosung
D.2.1.1.2	Name of the Marketing Authorisation holder	PUREN Pharma GmbH & Co. KG
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.3.1	Product name	Vinorelbina
D.3.2	Product code	[Vinorelbine]
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	VINORELBINA
D.3.9.1	CAS number	71486-22-1
D.3.9.2	Current sponsor code	Vinorelbina
D.3.9.4	EV Substance Code	SUB00069MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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: 4
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	Endoxan 1 g
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Oncology 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.3.1	Product name	Cyclophosphamide
D.3.2	Product code	[Cyclophosphamide]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
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	Cyclophosphamide
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB06859MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
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	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: 5
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	Navirel 10mg/ml Konzentrat zur Herstellung einer Infusionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	Medac Gesellschaft fur klinische
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.3.1	Product name	Vinorelbine
D.3.2	Product code	[NA]
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	VINORELBINE
D.3.9.1	CAS number	71486-22-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Vinorelbine
D.3.9.4	EV Substance Code	SUB00069MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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

Desmoplastic small round cell tumour (DSRCT)

Tumore desmoplastico a piccole cellule rotonde (DSRCT)

E.1.1.1

Medical condition in easily understood language

Desmoplastic small round cell tumour

Tumore desmoplastico a piccole cellule rotonde

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10064581
E.1.2	Term	Desmoplastic small round cell tumour
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 ramucirumab in combination with cyclophosphamide and vinorelbine compared with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT (DSRCT= desmoplastic small round cell tumor).

Valutare l'efficacia di ramucirumab in combinazione con ciclofosfamide e vinorelbina in comparazione al trattamento con ciclofosfamide e vinorelbina in pazienti pediatrici e giovani adulti con DSRCT (DSRCT= Tumore desmoplastico a piccole cellule rotonde)

E.2.2

Secondary objectives of the trial

-To evaluate the safety and tolerability of ramucirumab in combination with cyclophosphamide and vinorelbine compared with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT
- To characterize the PK of ramucirumab when co-administered with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT
- To assess the immunogenicity of ramucirumab when co-administered with cyclophosphamide and vinorelbine in pediatric and young adult patients with DSRCT

- valutare la sicurezza e la tollerabilità di ramucirumab in combinazione con ciclofosfamide e vinorelbina in comparazione con ciclofosfamide e vinorelbina in pazienti pediatrici e giovani adulti con DSRCT
- caratterizzare la PK di ramucirumab quando co-somministrato con ciclofosfamide e vinorelbina in pazienti pediatrici e giovani adulti con DSRCT
- valutare l'immunogenicità di ramucirumab quando co-somministrato con con ciclofosfamide e vinorelbina in pazienti pediatrici e giovani adulti con DSRCT

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- The washout-period after previous antibody therapy is defined as 4 half-lives after the last dose of the antibody
- Pediatric and young adult patients will be enrolled, where the specific age requirement for each indication will be specified in the protocol addenda.
- Patients must be >11 kg at the time of study enrollment.
- Patients with relapsed, recurrent, or refractory DSRCT.
- Patients must be 36 months to =29 years of age at the time of study enrollment.
- Patients must:
•have measurable disease by RECIST 1.1
•have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy). This prior treatment must
include approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
•not be eligible for surgical resection at time of enrollment.
- Patients who have a Lansky (<16 years of age; Lansky et al. 1987) or Karnofsky (=16 years of age; Karnofsky et al. 1948) performance score of at least 50.
- Patient with adequate hematologic, coagulation, liver, cardiac, renal
and bladder function, and adequate blood pressure (BP) control as per
protocol.

- Il periodo di washout dopo una terapia con anticorpi fatta in precedenza è definita come 4 emivite dopo l'ultima dose di anticorpi
- i pazienti pediatrici e i giovani adulti saranno arruolati nel momento in cui gli requisiti età-specifici per ciascuna indicazione sono specificati negli addendum al protocollo.
- i pazienti devono pesare >11 kg al momento dell'arruolamento nello studio.
- i pazienti con DSRCT con ricadute, refrattario e ricorrente.
- Pazienti devono avere più di 36 mesi fino a =29 anni di età al momento dell'arruolamento nello studio.
- i pazienti devono:
• avere una malattia misurabile tramite RECIST 1.1
• aver ricevuto almeno una linea di trattamento sistemica (incluse chemoterapie neoadiuvanti o adiuvanti). questo trattamento deve includere terapie approvate per le quali i pazienti sono eleggibili, a meno che il paziente non risulti essere un buon candidato per la terapia approvata.
• non eleggibile per la resezione chirurgica al momento dell'arruolamento.
- i pazienti che hanno un Lansky (<16 anni di età; Lansky et al. 1987) o Karnofsky (=16 anni di età; Karnofsky et al. 1948) performance score di almeno 50.
- Pazienti con funzioni ematiche, coagulazione, epatiche, cardiache, renali e veschicali adeguate e con pressione sanguigna adeguata come da protocollo.

E.4

Principal exclusion criteria

- Patients who have had allogeneic bone marrow or solid organ transplant are excluded.
- Patients who have active infections requiring therapy.
- Patients who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrolment are not eligible.
- Patients with a bowel obstruction, extensive intestinal resection or history or presence of inflammatory enteropathy or other GI pathology as per protocol.
- Patients with a history of hepatorenal syndrome.
- Patients with evidence of active bleeding or a history of significant (=Grade 3) bleeding event, deep vein thrombosis requiring medical intervention (including pulmonary embolism), hemoptysis or other signs of pulmonary haemorrhage, or esophageal varices within 3 months of enrollment are not eligible.
- Patients with a bleeding diathesis or vasculitis are not eligible.
- Patients with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of study enrollment are not eligible.
- Patients with myocardial infarction or unstable angina within the prior 6 months.
- Patients with significant vascular disease or peripheral vascular disease.
- Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.
- Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment are not eligible.
- Patients previously treated and progressed on combination cyclophosphamide and vinorelbine regimen. (Patients who received combination as maintenance therapy, without progression, would be eligible.)
- Patients with known hypersensitivity to ramucirumab, cyclophosphamide or vinorelbine.
- Patients who have previously received any exposure to ramucirumab are not eligible.
-Patients with CNS involvement are ineligible.

- pazienti con trapianto allogenico di midollo osseo o trapianto di organo solido sono esclusi
- pazienti che hanno infezioni attive che richiedono terapie
- pazienti che hanno storia di fistula, ulcere gastrointestinali o perforazioni, o ascessi intra-addominali entro 3 mesi dall'iscrizione allo studio non sono eleggibili
- pazienti con un'ostruzione intestinale, una resezione intestinale estensiva o una storia o presenza di enteropatia infiammatoria o altra patologia GI come da protocollo
- pazienti con storia di sindrome epatorenale
- pazienti con evidenza di sanguinamento attivo o anamnesi di sanguinamento significativo (= Grado 3), trombosi venosa profonda che richiede intervento medico (inclusa embolia polmonare), emottisi o altri segni di emorragia polmonare o varici esofagee entro 3 mesi dall'arruolamento non sono eleggibili
- pazienti con diatesi sanguinante o vasculite non sono eleggibili
- pazienti con storia di eventi di CNS arteriale/venosa tromboembolitica (VTEs) inclusi attacchi ischemici transienti (TIA) o incidenti cerebrovascolari (CVA) entro 6 mesi dall'arruolamento non sono eleggibili
- pazienti con infarto del miocardio o angina instabile entro 6 mesi dall'arruolamento
- pazienti con malattia vascolare significativa o malattia vascolare periferica
- pazienti con anamnesi di crisi ipertensiva o encefalopatia ipertensiva entro 6 mesi dall'arruolamento allo studio non sono eleggibili
- pazienti che hanno una ferita che non guarisce, una frattura non guarita o guarita in modo incompleto o una frattura ossea composta (aperta) al momento dell'arruolamento non sono eleggibili
- pazienti precedentemente trattati e progrediti in regime combinato di ciclofosfamide e vinorelbina. (I pazienti che hanno ricevuto una combinazione come terapia di mantenimento, senza progressione, sarebbero idonei)
- pazienti con nota ipersensibilità a ramucirumab, ciclofosfamide o vinorelbina.
- pazienti che hanno precedentemente ricevuto qualsiasi esposizione a ramucirumab non sono idonei.
-pazienti con coinvolgimento CNS non sono elegibili

E.5 End points

E.5.1

Primary end point(s)

progression-free survival (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will be triggered when PFS events have occurred for approximately 80% of the enrolled patients

L'analisi primaria verrà effettuata quando si saranno verificati eventi PFS per circa l'80% dei pazienti arruolati

E.5.2

Secondary end point(s)

Serious adverse event, Adverse event, Safety laboratory assessments, Vital signs, Overall response rate, Duration of response, Complete response, Incidence of immunogenicity, Cmax (maximum concentration) and Cmin (minimum concentration)

SAE, AE, valutazioni di sicurezza di laboratorio, segni vitali, tasso di risposta generale, durata della risposta, risposta completa, incidenza di immunogenicità, Cmax (concentrazione massima) e Cmin (concentrazione minima)

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout study

Durante il corso dello studio

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

therapeutic exploratory (phase II)

valutazione terapeutica (fase II)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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

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

Information not present in EudraCT

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

Australia

Japan

United States

Belgium

France

Germany

Italy

Netherlands

Spain

United Kingdom

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 - Last visit or last scheduled procedure for the last patient.

LVLS - ultima visita o ultima procedura schedulata per l'ultimo paziente

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

The patient’s parent/guardian, has given written informed consent (and assent, as applicable) and authorization for release of health/information for research prior to any study-specific procedures being performed.

i genitori/rappresentati legali del paziente hanno dato il consenso informato scritto (e l'assenso, a seconda dei casi) e l'autorizzazione per il rilascio di informazioni / salute per la ricerca prima che vengano eseguite le procedure specifiche dell

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)

None

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	The Experimental Cancer Medicine Centres
G.4.3.4	Network Country	United Kingdom
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Children's Oncology Group Operations Center
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-26

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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