Clinical Trials Register

Summary
EudraCT Number:	2013-002405-61
Sponsor's Protocol Code Number:	IPI-145-07
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-12-02
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

Spain - AEMPS

A.2

EudraCT number

2013-002405-61

A.3

Full title of the trial

A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Estudio clínico comparativo de fase III sobre la eficacia entre el IPI-145 y el ofatumumab en pacientes con leucemia linfocítica crónica o linfoma linfocítico de célula pequeña resistentes al tratamiento o recidivantes

A.3.1

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

Study to assess the safety and efficacy of the study drug IPI-145 in Leukaemia patients compared with Ofatumumab

Estudio para evaluar la seguridad y la eficacia del medicamento en estudio IPI-145 en pacientes con leucemia comparado con ofatumumab

A.4.1

Sponsor's protocol code number

IPI-145-07

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1138-8603

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	Infinity Pharmaceuticals, 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	Infinity Pharmaceuticals, 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	Infinity Pharmaceuticals, Inc
B.5.2	Functional name of contact point	Darlene Noci
B.5.3	Address:
B.5.3.1	Street Address	780 Memorial Drive
B.5.3.2	Town/ city	Cambridge, MA
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
B.5.4	Telephone number	0016174531391
B.5.5	Fax number	0016174531001
B.5.6	E-mail	Darlene.noci@infi.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/196/12
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
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 yet available
D.3.9.1	CAS number	1201438-56-3
D.3.9.3	Other descriptive name	IPI-145
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	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	Yes
D.2.1.1.1	Trade name	Ofatumumab
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Group 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	ARZERRA
D.3.4	Pharmaceutical form	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	OFATUMUMAB
D.3.9.1	CAS number	679818-59-8
D.3.9.4	EV Substance Code	SUB25221
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	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	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

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Leucemia linfocítica crónica
Linfoma linfocítico de célula pequeña

E.1.1.1

Medical condition in easily understood language

n/a

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10008976
E.1.2	Term	Chronic lymphocytic leukemia
E.1.2	System Organ Class	100000004864

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 examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Analizar la eficacia de la monoterapia con IPI-145 en comparación con la monoterapia con ofatumumab en pacientes con leucemia linfocítica crónica (LLC) o linfoma linfocítico de células pequeñas (LLCP).

E.2.2

Secondary objectives of the trial

To determine the safety of IPI-145 in subjects with CLL and SLL
To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s)

Determinar la seguridad de IPI-145 en pacientes con LLC y LLCP.
Evaluar la farmacocinética (FC) de IPI-145 y, si procede, la de sus metabolitos.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

There is an optional sub study for Pharmacogenomics. There is not a separate protocol, it is included in the main protocol.

Hay un sub estudio opcional farmacogenómico. No hay un protocolo separado, está incluído en el protocolo principal.

E.3

Principal inclusion criteria

1.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment
2. Must have received at least one prior therapy for CLL/SLL
3. Measureable nodal disease by CT
4. ECOG performance status of 0-2
5. Considered not appropriate for treatment or retreament with purine analog-based therapy
6. Cytogenetics or Fish performed within 24 months prior to randomization

1. Estar diagnosticado de una LLC o LLCP activa que cumple al menos uno de los criterios del IWCLL de 2008 por los que se requiere tratamiento.
2. Heber recibido previamente algún tratamiento para LLC/ LLCP
3. Que su enfermedad sea medible detectado por tomografía axial computerizada (TAC).
4. Que su estado de salud general sea de 0 a 2
5. No ser el candidato adecuado para recibir un tratamiento o repetir un tratamiento basado en análogos de purina.
6. Disponer de pruebas citogenéticas o de la prueba FISH de las células de LLC en los dos años previos a la aleatorización

E.4

Principal exclusion criteria

1.History of Richter's transformation or prolymphocytic leukemia
2. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP)
3.Prior allogeneic transplant
4.Known central nervous system (CNS) lymphoma or leukemia
5. Previous treatment with a PI3K inhibitor
6. Tyrosine kinase inhibitor within 7 days of randomization
7.Ongoing systemic bacterial, fungai, or viral infections at the time of treatment
8. Unable to receive prophylactic treatment for pneumocytosis or herpes simplex virus
9. History of tuberculosis within preceding two years
10.Prior, current or chronic hepatitis B or hepatitis C infection
11.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months

1. Antecedentes de leucemia prolinfocítica o de síndrome de Richter.
2. Anemia hemolítica autoinmunitaria (AHA) o púrpura trombocitopénica idiopática (PTI) no controlada.
3. Alotrasplante previo
4. Leucemia o linfoma del sistema nervioso central (SNC).
5. Exposición previa a un inhibidor de las fosfoinositida-3-cinasas (PI3K),
6. Inhibidor de la tirosina cinasa los siete días anteriores a la aleatorización.
7. Infecciones víricas, fúngicas o bacterianas sistémicas en curso en el momento de iniciar el tratamiento en estudio.
8. Estar incapacitado para recibir un tratamiento profiláctico para la infección por Pneumocystis jiroveci o por el virus del herpes simple (VHS).
9. Antecedentes de tuberculosis en los dos años precedentes.
10. Infección por hepatitis B o C crónica, activa o previa.
11. Antecedentes de ictus, angina inestable, infarto de miocardio o arritmia ventricular que ha precisado medicación o control mecánico en los últimos seis meses.

E.5 End points

E.5.1

Primary end point(s)

PFS defined as time from randomization to the first documentation of progressive disease (PD) as determined by independent review or death due to any cause

SSP definida como el tiempo transcurrido desde la aleatorización hasta la primera vez que se documenta la progresión de la enfermedad (PE) determinada por un examen independiente o la muerte del paciente por cualquier causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

Progression of disease or Death

Progresión de la enfermedad o muerte

E.5.2

Secondary end point(s)

TEAEs and changes in safety laboratory values
OS defined as time from randomization to death
Overall Response Rate (ORR) (based on independent
assessment), defined as a complete response/remission (CR),
CR with incomplete marrow recovery (CRi), partial
response/remission (PR), nodular PR, or PR with
lymphocytosis, according to the International Workshop on
Chronic Lymphocytic Leukemia (IWCLL) Response Criteria,
with modification for treatment-related lymphocytosis

AAST y los cambios en los valores de la seguridad del laboratorio.
SG definida como el tiempo transcurrido entre la aleatorización y la muerte del paciente.
La tasa de respuesta global (TRG) , definida como una remisión o respuesta completa (RC), una RC con una recuperación incompleta de la médula (RCi), una remisión o respuesta parcial (RP), una RP nodular o una RP con linfocitosis, de conformidad con los criterios de respuesta del IWCLL, con modificación de la linfocitosis relacionada con el tratamiento.
La duración de la respuesta (DR), definida como una remisión o respuesta completa (RC), una RC con una recuperación incompleta de la médula (RCi), una remisión o respuesta parcial (RP), una RP nodular o una RP con linfocitosis, de conformidad con los criterios de respuesta del IWCLL, con modificación de la linfocitosis relacionada con el tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Overall survival

supervivencia global

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

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

ofatumumab

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

Australia

Belgium

France

Germany

Hungary

Italy

Austria

New Zealand

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

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:

207

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

174

F.4.2.2

In the whole clinical trial

307

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)

IPI-145-12 or Standard of care

IPI-145-12 o tratamiento estandar

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

2014-02-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-01-16

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

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