Clinical Trials Register

Summary
EudraCT Number:	2013-004008-20
Sponsor's Protocol Code Number:	IPI-145-06
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-06-19
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2013-004008-20

A.3

Full title of the trial

A Phase 2 Study of IPI-145 in Subjects with Refractory Indolent Non-Hodgkin Lymphoma.

Klinické hodnocení fáze 2 hodnotící IPI-145 u pacientů s refrakterním indolentním non-Hodgkinovým lymfomem

A.3.1

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

Efficacy, safety and tolerability of IPI-145 in subjects diagnosed with indolent Non-Hodgkin Lymphoma.

A.4.1

Sponsor's protocol code number

IPI-145-06

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01882803

A.5.4

Other Identifiers

Name:

IND

Number:

112,486

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	IPI-145-06 Trial Information
B.5.3	Address:
B.5.3.1	Street Address	117 Kendrick St.
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	+1781292 4200
B.5.5	Fax number	+1617812 0059
B.5.6	E-mail	gberk@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	IPI-145
D.3.2	Product code	IPI-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	Not available yet
D.3.9.1	CAS number	1386861-49-9
D.3.9.2	Current sponsor code	IPI-145
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	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: 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	IPI-145
D.3.2	Product code	IPI-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	Not available yet
D.3.9.1	CAS number	1386861-49-9
D.3.9.2	Current sponsor code	IPI-145
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	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

Refractory Indolent Non-Hodgkin Lymphoma

E.1.1.1

Medical condition in easily understood language

indolent Non-Hodgkin’s Lymphoma (iNHL)

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10029627
E.1.2	Term	Non-Hodgkin's lymphoma unspecified histology intermediate grade refractory
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

To evaluate the antitumor activity of IPI-145 administered to subjects diagnosed with indolent non-Hodgkin lymphoma (iNHL) (defined as follicular lymphoma [FL], marginal zone lymphoma [MZL; splenic, nodal and extranodal], or small lymphocytic lymphoma [SLL]) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

E.2.2

Secondary objectives of the trial

Secondary objectives:
• To evaluate the safety of IPI-145 in all subjects
• To evaluate additional efficacy parameters in all subjects
• To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects who have been diagnosed with indolent NHL that has progressed.
•Subjects must have exhibited no response or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
•Subjects must have rituximab-refractory disease.
•Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT.
•Adequate renal and hepatic function.

E.4

Principal exclusion criteria

•Candidate for potentially curative therapies in the opinion of the investigator.
•Previous treatment with any PI3K inhibitor or BTK inhibitor.
•Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
•Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
•Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
•Symptomatic central nervous system (CNS) NHL.
•Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate (ORR), with overall response defined as best response of complete response/remission (CR) or partial response/remission (PR) according to the revised International Working Group (IWG) Criteria

E.5.1.1

Timepoint(s) of evaluation of this end point

CT scans of chest, abdomen and pelvis & focused physical examination and assessment of B symptoms & response assessment: screening, Day -7 to Day 1 of Cycles 3, 5, 7, 10, 14, 18 and every 4th cycle thereafter, end of treatment
Bone marrow biopsy and bone marrow aspiration: screening, Day -7 to Day 1 of Cycles 3, 5, 7, 10, 14, 18 and every 4th cycle thereafter

E.5.2

Secondary end point(s)

Secondary endpoints:
• Treatment-emergent adverse events (TEAEs), ECG measures, and changes in safety laboratory values
• Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of progressive disease (PD) or death due to any cause
• Progression-free survival (PFS),
• Overall survival (OS)
• Time to response (TTR)
• PK parameters derived from plasma IPI-145 concentrations and, if applicable, its metabolite(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

AE/SAE: screening, cycles 1 (Day 1 & 15) to 8 and beyond (every 2 cycles), end of treatment and 30 days post-treatment
PK blood sample collection: Day 15 of Cycle 1, Day 1 of Cycles 2 and 3
ECG: Day 1 and 15 of Cycle 1

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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)

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

Yes

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

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

Belarus

Belgium

Bulgaria

Canada

Czech Republic

France

Georgia

Hungary

Italy

Spain

United Kingdom

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

Last survival follow-up visit/communication for the last patient.Subjects will be followed for survival for up to 3 years after their first dose of IPI-145. The maximum number of months to complete the study is expected to be approximately 66 months.

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

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)

Subjects will receive a starting dose of 25 mg IPI-145 BID over the course of 28-day treatment cycles for up to 13 cycles. After completing 13 treatment cycles of IPI-145, subjects who, in the judgment of the investigator, may derive benefit from continued treatment, may continue to receive additional cycles of IPI-145 until disease progression or unacceptable toxicity.

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

2014-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-11-05

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials