Clinical Trials Register

Summary
EudraCT Number:	2015-001316-34
Sponsor's Protocol Code Number:	I5B-MC-JGDL
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:	2021-05-24
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

2015-001316-34

A.3

Full title of the trial

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and
Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Studio di fase 1b (in aperto) / fase 2 (randomizzato, in doppio cieco) volto a valutare gemcitabina e docetaxel con o senza olaratumab nel trattamento del sarcoma dei tessuti molli avanzato

A.3.1

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

A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel

Studio del sarcoma dei tessuti molli con Olaratumab Gemcitabina e Docetaxel

A.3.2

Name or abbreviated title of the trial where available

ANNOUNCE 2

A.4.1

Sponsor's protocol code number

I5B-MC-JGDL

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 Lilli 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
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	IN46285
B.5.3.4	Country	United States
B.5.4	Telephone number	0554257386
B.5.5	Fax number	0554257348
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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/15/1447
D.3 Description of the IMP
D.3.1	Product name	Olaratumab
D.3.2	Product code	[LY30112207]
D.3.4	Pharmaceutical form	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	Olaratumab
D.3.9.1	CAS number	1024603-93-7
D.3.9.2	Current sponsor code	LY3012207
D.3.9.4	EV Substance Code	SUB67904
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	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	Gemzar
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly and Company Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Gemcitabina
D.3.2	Product code	na
D.3.4	Pharmaceutical form	Powder 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	GEMCITABINA CLORIDRATO
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	GEMCITABINA CLORIDRATO
D.3.9.4	EV Substance Code	SUB02324MIG
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	1000
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	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	Docetaxel Hospira
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Docetaxel Hospira
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	DOCETAXEL
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Docetaxel
D.3.9.4	EV Substance Code	SUB12492MIG
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

soft tissue sarcoma

sarcoma dei tessuti molli

E.1.1.1

Medical condition in easily understood language

Cancer in soft tissues of the body, including muscle, tendons, fat, lymph vessels, blood vessels, nerves, and tissue around joints

Cancro ai tessuti molli del corpo che comprendono: muscoli, tendini, tessuto adiposo, vasi linfatici, nervi e tessuti articolari

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	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10041298
E.1.2	Term	Soft tissue sarcomas histology unspecified
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	15.1
E.1.2	Level	HLGT
E.1.2	Classification code	10041299
E.1.2	Term	Soft tissue sarcomas
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

The primary objective of the Phase 1b part is to determine a recommended Phase 2 dose of olaratumab that may be safely administered in combination with gemcitabine and docetaxel to patients with advanced or metastatic STS.
The primary objective of the Phase 2 part is to compare the overall survival (OS) in patients with advanced or metastatic STS treated with olaratumab plus gemcitabine and docetaxel versus placebo plus gemcitabine and docetaxel.

L’obiettivo primario della parte di fase 1b è determinare una dose di olaratumab raccomandata per la fase 2 che potrà essere somministrata con sicurezza in associazione a gemcitabina e docetaxel in pazienti con STS avanzato o metastatico.
L’obiettivo primario della parte di fase 2 è confrontare la sopravvivenza globale (OS) in pazienti con STS avanzato o metastatico trattati con olaratumab più gemcitabina e docetaxel o con placebo più gemcitabina e docetaxel.

E.2.2

Secondary objectives of the trial

The secondary objectives of Phase 1b part are to:
• characterize the safety and toxicity profile of olaratumab in combination with gemcitabine and docetaxel
• evaluate the PK and immunogenicity of olaratumab in combination with gemcitabine and docetaxel
• evaluate the PK of gemcitabine and docetaxel in combination with olaratumab
• document any antitumor activity of gemcitabine and docetaxel in combination with olaratumab
The secondary objectives of the Phase 2 part are to compare olaratumab plus gemcitabine and docetaxel versus placebo plus gemcitabine and docetaxel for the following:
• progression-free survival (PFS)
• objective response rate (ORR) (complete response [CR] + partial response [PR])
• disease control rate (DCR; CR + PR + stable disease)
• patient-reported outcomes (PROs): Pain, Health-related Quality of Life (HRQoL), and health status
• safety and tolerability
• evaluate the PK and immunogenicity of olaratumab

Gli obiettivi secondari della parte di fase 1b sono:
• caratterizzare il profilo di sicurezza e tossicità di olaratumab in associazione a gemcitabina e docetaxel
• valutare la farmacocinetica e l’immunogenicità di olaratumab in associazione a gemcitabina e docetaxel
• valutare la farmacocinetica di gemcitabina e docetaxel in associazione a olaratumab
• documentare l’eventuale attività antitumorale di gemcitabina e docetaxel in associazione a olaratumab
Gli obiettivi secondari della parte di fase 2 consistono nel confrontare olaratumab più gemcitabina e docetaxel rispetto al placebo più gemcitabina e docetaxel in termini di:
• sopravvivenza libera da progressione (PFS)
• tasso di risposta obiettiva (ORR) (risposta completa [CR] + risposta parziale [PR])
• tasso di controllo della malattia (DCR: CR + PR + malattia stabile)
• esiti riferiti dai pazienti (PRO): dolore, qualità di vita correlata alla salute (HRQoL) e stato di salute
• sicurezza e tollerabilità
• valutazione della farmacoc

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine, docetaxel, and olaratumab naïve, with histologically confirmed, locally advanced, unresectable or metastatic STS, and not amenable to curative treatment with surgery or radiotherapy. The patient may have received at most 2 previous lines of systemic therapy (neoadjuvant and adjuvant therapies will not be considered as prior therapy) for locally advanced or metastatic disease and is suitable for receiving gentamicitabine and docetaxel therapy. antitumor should be completed more than 3 weeks (= 3 weeks (21 days)) before receiving the first dose of study medication.
In phase 2 the previous combination therapy with olaratumab / doxorubicin in a treatment line is allowed.
Previous olaratumeb therapy must have been with doxorubicin as indicated on the olaratumab label.
Prior therapy with olaratumab must have included at least 2 complete cycles of olaratumab / doxorubicin (ie a minimum of 4 doses of oloratumab).
Patients who have completed at least 2 courses of therapy with olaratumab / doxorubicin in combination and who have suspended doxorubicin due to maximum toxicity or dose and continued with olaratumab as monotherapy are still suitable. the last most recent dose of olaratumab must have been taken within 180 days of randomization in this study.

Pazienti con: età pari o superiore a 16 anni, ECOG PS da 0 a 1, nessuna esposizione pregressa a gemcitabina e docetaxel, affetti da Sarcoma dei Tessuti molli localmente avanzato, non resecabile o metastatico istologicamente confermato e non trattabile mediante intervento chirurgico o radioterapia con intento curativo. Il paziente può aver ricevuto al massimo 2 linee precedenti di terapie sistemiche (le terapie neoadiuvanti e adiuvanti non saranno considerate come precedenti linea di terapia) per malattia localmente avanzata o metastatica ed è idoneo a ricevere la terapia con gentamicitabina e docetaxel. Tutti i precedenti trattamenti antitumorali devono essere stati completati da più di 3 settimane (= 3 settimane ( 21 giorni)) prima di ricevere la prima dose di farmaco in studio.
Nella fase 2 la precedente terapia di associazione con olaratumab/doxorubicina in una linea di trattamento e consentita.
La precedente terapia con olaratumeb deve essere stata con doxorubicina come indicato sull'etichetta di olaratumab.
La precedente terapia con olaratumab deve aver incluso almeno 2 cicli completi di olaratumab/doxorubicina (ovvero un minimo di 4 dosi di olaratumab).
Pazienti che hanno completato almeno 2 cicli di terapia con olaratumab/doxorubicina in combinazione e che hanno sospeso la doxorubicina a causa di tossicità o dosaggio massimo e hanno proseguito con olaratumab in monoterapia sono comunque idonei. L'ultima dose più recente di olaratumab deve essere stata assunta entro 180 giorni dalla randomizzazione in questo studio.

E.4

Principal exclusion criteria

Patients with gastrointestinal stromal tumor or Kaposi’s sarcoma will be excluded. Patients previously enrolled in Study I5B-MC-JGDJ or any other blinded study with olaratumab are not eligible to participate in this trial.

Pazienti: con tumore stromale gastrointestinale o un sarcoma di Kaposi, che hanno preso parte precedentemente allo studio I5B-MC-JGDJ o ad un qualsiasi altro studio in cieco con olaratumab

E.5 End points

E.5.1

Primary end point(s)

Efficacy: Overall survival (time from randomization to death) is the primary per-patient measure for efficacy in the Phase 2 part.

Efficacia: la sopravvivenza globale (tempo intercorrente tra la randomizzazione e il decesso) costituisce il parametro individuale primario per la valutazione dell’efficacia nella parte di fase 2.

E.5.1.1

Timepoint(s) of evaluation of this end point

This study will be considered complete (ie, the scientific evaluation will be completed [completion of the study]) after final analysis of the endpoint on overall survival (<< SW >> at least 108 global survival events in the arm of naive patients olaratumab) was performed and evaluated, as determined by Lilly. << JGDL (a) >> Investigators will continue to follow the study program for all patients until Lilly notifies completion of the study. Radiographic assessments according to Response Evaluation Criteria In Solid Tumors, Version 1.1 criteria, will be performed every 6 weeks (±7 days) until radiographic documentation of PD.

Questo studio sarà considerato completo (vale a dire, la valutazione scientifica sarà completata [completamento dello studio]) dopo l'analisi finale dell'endpoint sulla sopravvivenza globale (<< SW>> almeno 108 eventi di sopravvivenza globale nel braccio dei pazienti naive ad olaratumab) è stato eseguito e valutato, come dederminato da Lilly . << JGDL (a) >> Gli sperimentatori continueranno a seguire il programma dello studio per tuti i pazienti fino a quando Lilly non notificherà il completamento dell studio. Ogni 6 settimane (±7 giorni) fino alla documentazione radiografica di PD verranno eseguite delle valutazioni radiografiche secondo i criteri RECIST (Response Evaluation Criteria in Solid Tumors), versione 1.1.

E.5.2

Secondary end point(s)

The secondary objective is to compare olaratumab plus gemcitabine and docetaxel versus placebo plus gemcitabine and docetaxel for the following:
• progression-free survival (PFS)

L'obiettivo secondario consiste nel confrontare olaratumab più gemcitabina e docetaxel rispetto al placebo più gemcitabina e docetaxel in termini di:
• sopravvivenza libera da progressione (PFS)

E.5.2.1

Timepoint(s) of evaluation of this end point

Conclusion of phase II trial

Conclusione della fase II 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

Yes

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

Phase I not applicable for Italy.

Fase I non applicabile per l'Italia.

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

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)

Yes

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

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

Israel

United States

France

Germany

Hungary

Italy

Poland

Spain

United Kingdom

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

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)

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:

172

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Pediatric patients age 16-18 years

Pazienti in età compresa tra 16 e 18 anni

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

113

F.4.2.2

In the whole clinical trial

314

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)

Subjects who discontinue study treatment for any reason without disease progression will have imaging and tumor assessments every six weeks.

Continued access: After study completion, patients on study treatment who continue to experience clinical benefit and no undue risks, in the opinion of the investigator, may continue to receive olaratumab until one of the criteria for discontinuation is met. A continued access follow-up visit will occur 30 days (±7 days) after discontinuation.

I paz.che interrompono il tratt. per qualsiasi ragione senza progressione della malattia saranno sottoposti valutazioni di imaging ogni sei settimane. Accesso continuo:Dopo il completamento dello studio,i paz. in trattamento che riscontrano un beneficio clinico e nessun rischio eccessivo,a giudizio dello sperim, possono continuare a ricevere olaratumab fino a quando uno dei criteri per l'interruzione è soddisfatto.Una visita di followup per l'accesso continuo avverrà 30 gg±7 dopo la sospensione.

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

2018-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-16

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

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