Clinical Trials Register

Summary
EudraCT Number:	2016-000848-34
Sponsor's Protocol Code Number:	IPl-145-23
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:	2022-01-20
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

2016-000848-34

A.3

Full title of the trial

Long term, Continued Treatment and Follow up Study in Subjects with Hematologic Malignancies Treated with Duvelisib (IPI 145)

Studio a lungo termine di continuazione del trattamento e follow-up in soggetti con neoplasie ematologiche trattati con duvelisib (IPI-145)

A.3.1

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

A follow-up study in patients with hematologic malignancies that are treated with experimental drug duvelisib

Studio di follow up in pazienti con neoplasie ematologiche trattati con ii farmaco in sperimentazione duvelisib

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

IPl-145-23

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02711852

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	Verastem, INC
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	Verastem, Inc
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	Verastem, Inc
B.5.2	Functional name of contact point	Hagop Youssoufian
B.5.3	Address:
B.5.3.1	Street Address	117 Kendrick Street, Suite 500
B.5.3.2	Town/ city	Needham
B.5.3.3	Post code	MA 02494
B.5.3.4	Country	United States
B.5.4	Telephone number	0017812924200
B.5.5	Fax number	0016178120059
B.5.6	E-mail	hyoussoufian@verastem.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	EMA/OD/047/13
D.3 Description of the IMP
D.3.1	Product name	Duvelisib
D.3.2	Product code	[IPl-145]
D.3.4	Pharmaceutical form	Capsule, hard
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	Duvellsib
D.3.9.1	CAS number	1386861-48-9
D.3.9.2	Current sponsor code	IPl-145
D.3.9.3	Other descriptive name	/
D.3.9.4	EV Substance Code	SUB62340
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	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	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	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	EMA/OD/047/13
D.3 Description of the IMP
D.3.1	Product name	Duvelisib
D.3.2	Product code	[IPl-145]
D.3.4	Pharmaceutical form	Capsule, hard
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	Duvellslb
D.3.9.1	CAS number	1386861-48-9
D.3.9.2	Current sponsor code	IPl-145
D.3.9.3	Other descriptive name	/
D.3.9.4	EV Substance Code	SUB62340
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	25
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

Hematologic Malignancies

Neoplasie Ematologiche

E.1.1.1

Medical condition in easily understood language

Hematologic Malignancies

Neoplasie Ematologiche

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	LLT
E.1.2	Classification code	10066481
E.1.2	Term	Hematological malignancy
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to capture long term safety data in subjects with hematologic malignancies treated with duvelisib.

L'obiettivo primario di questo studio è di acquisire dati sulla sicurezza a lungo termine in soggetti con neoplasie ematologiche trattati con duvelisib

E.2.2

Secondary objectives of the trial

•The long term clinical activity of duvelisib in subjects with hematologic
malignancies.
•OS of subjects with hematologic malignancies treated with duvelisib.

Acquisire dati sull'attivita clinica a lungo termine di duvelisib in soggetti con neoplasie ematologiche - Acquisire dati sulla OS di soggetti con neoplasie ematologiche trattati con duvelisib

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Have participated in a previous study of duvelisib, and:
• Be actively receiving duvelisib monotherapy on the previous study (within 14 days of study entry) and demonstrating clinical benefit (complete response [CR]/ partial response [PR]/ stable disease [SD]) of continued use, or
• Be in the survival follow-up phase of a previous duvelisib study
• Have completed the required components of the previous study and be appropriate for enrollment into this long-term continued treatment and follow-up study, as determined by the Sponsor

Per essere idonei alla partecipazione allo studio, e necessario che tutti i soggetti abbiano partecipato a un precedente studio con duvelisib e:
a. siano attivamente sottoposti a monoterapia con duvelisib in base allo studio precedente (entro 14 giorni dall'ammissione allo studio) e manifestino un beneficio clinico evidente [risposta completa
(CR)/risposta parziale (PR)/malattia stabile (SD)] in seguito all'uso continue oppure
b. siano nella fase di follow up per la sopravvivenza di un precedente studio con duvelisib;
2. abbiano completato i componenti obbligatori dello studio precedente e siano idonei all'arruolamento in questo studio a lunge termine di continuazione del trattamento e follow up, come determinate dallo Sponsor

E.4

Principal exclusion criteria

Subjects actively receiving duvelisib are to be excluded from this study if theyHave any ongoing = Grade 3 AE considered related to duvelisib treatment at screening

Soggetti che ricevono attivamente duvelisib devono essere esclusi dallo studio se allo screening manifestano un evento avverso = grado 3 considerato correlato al trattamento con duvelisib

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints in this study are adverse events (AEs) and safety laboratory test values.

Gli end point primari dello studio sono gli Eventi Avversi e i valori degli esami di laboratorio per la sicurezza.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

There are no formal secondary endpoints planned for this long term study. Data will be captured to support the clinical endpoints based on the disease response assessment and OS as defined in the subject's previous study.

Non sono previsti endpoint secondari formali per questo studio a lungo termine. Saranno acquisiti dati finalizzati a supportare gli endpoint clinici sulla base della valutazione della risposta alla malattla e della OS secondo la definizione fornita nello studio a cui ii soggetto ha partecipato in precedenza.

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

E.6.4

Safety

Yes

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

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

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

Italy

Poland

United States

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

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)

Patients would be followed through the survival follow-up period per protocol – Standard of Care will be provided after study treatment termination.

i pazienti saranno seguiti per II periodo di follow up come da protocollo. Cure da normale pratica clinica verranno dispensate dopo la fine del trattamento

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

2016-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-05-04

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