Clinical Trials Register

Summary
EudraCT Number:	2013-003639-31
Sponsor's Protocol Code Number:	IPI-145-12
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-12-05
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

2013-003639-31

A.3

Full title of the trial

A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07

Estudio de IPI-145 y ofatumumab en pacientes con leucemia linfocítica crónica/linfoma linfocítico de células pequeñas incluidos previamente en el estudio IPI-145-07

A.3.1

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

Study to assess the safety of the study drug IPI-145 or ofatumumab in leukemia patients

Estudio para evaluar la seguridad del medicamento en investigación IPI-145 o ofatumumab en pacientes con leucemia.

A.4.1

Sponsor's protocol code number

IPI-145-12

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	001617682
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.3.9.2	Current sponsor code	IPI-145
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.3.9.2	Current sponsor code	n/a
D.3.9.3	Other descriptive name	n/a
D.3.9.4	EV Substance Code	SUB25221
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
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 células pequeñas

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 in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with ofatumumab in Study IPI-145-07.
To examine the efficacy of ofatumumab monotherapy in subjects who experienced disease progression after treatment with IPI 145 or ofatumumab in Study IPI-145-07

Investigar la eficacia de IPI-145 en monoterapia en pacientes con leucemia linfocítica crónica (LLC) o linfoma linfocítico de células pequeñas (LLCP) que sufrieron una progresión de la enfermedad tras el tratamiento con ofatumumab en el estudio IPI-145-07.
Investigar la eficacia de ofatumumab en monoterapia en pacientes que experimentaron una progresión de la enfermedad tras el tratamiento con IPI-145 u ofatumumab en el estudio IPI-145-07.

E.2.2

Secondary objectives of the trial

To determine the safety of IPI-145 and ofatumumab in subjects with CLL and SLL who experienced disease progression after treatment with IPI 145 in Study IPI-145-07

Determinar la seguridad de IPI-145 y ofatumumab en pacientes con LLC y LLCP que experimentaron una progresión de la enfermedad tras el tratamiento con IPI-145 en el estudio IPI-145-07

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Received either IPI 145 or ofatumumab while participating in Study IPI 145-07 and experienced radiologic disease progression
2.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008
criteria for requiring treatment
3. Must have received at least one prior therapy for CLL/SLL
4. Measureable nodal disease by CT
5. ECOG performance status of 0-2
6. Considered not appropriate for treatment or retreament with purine
analog-based therapy
7. Cytogenetics or Fish performed within 24 months prior to
randomization

1. Recibieron IPI-145 u ofatumumab durante su participación en el estudio IPI-145-07 y experimentaron una progresión radiológica de su enfermedad.
2. Diagnóstico de LLC o LLCP activo que cumpla al menos uno de los criterios del IWCLL de 2008 para requerir tratamiento
3. Debe haber recibido al menos un tratamiento previo para la leucemia linfocítica crónica/linfoma linfocítico de células pequeñas.
4. Enfermedad medible con un ganglio linfático o masa tumoral mediante TAC.
5. ECOG de 0 a 2.
6. No ser el candidato adecuado para recibir un tratamiento o repetir un tratamiento basado en análogos de purina.
7. 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

Subjects are to be excluded from the study if they meet any of the following criteria:
1.Discontinued participation in Infinity-sponsored IPI-145-07 study for reasons other than disease progression
2.History of Richter's transformation or prolymphocytic leukemia
3. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP)
4.Prior allogeneic transplant
5.Known central nervous system (CNS) lymphoma or leukemia
6. Previous treatment with a PI3K inhibitor
7. Tyrosine kinase inhibitor within 7 days of randomization
8.Ongoing systemic bacterial, fungai, or viral infections at the time of
treatment
9. Unable to receive prophylactic treatment for pneumocytosis or herpes
simplex virus
10. History of tuberculosis within preceding two years
11.Prior, current or chronic hepatitis B or hepatitis C infection
12.History of stroke, unstable angina, myocardial infarction, or
ventricular arrhythmia requiring medication or mechanical control within
the last 6 months

Se excluirá a los pacientes del estudio si cumplen alguno de los criterios siguientes:
1. Interrupción de la participación en el estudio IPI-145-07 por motivos que no sean la progresión de la enfermedad.
2. Transformación de Richter o leucemia prolinfocítica.
3. Autoimmune haemolytic anemia (AIHA) or idiopathic
thrombocytopenia purpura (ITP).
4. Alotrasplante previo.
5. Linfoma del sistema nervioso central (SNC) o leucemia conocidos.
6. tratamiento previo con inhividor PI3K.
7. Inhibidor de la tirosina quinasa dentro de los 7 días de la aleatorización.
8. Infecciones bacterianas, fúngicas o víricas sistémicas en curso en el momento del inicio del tratamiento del estudio.
9. Estar incapacitado para recibir tratamiento profiláctico para la infección por Pneumocystis o por el virus del herpes simple.
10. Antecedentes de tuberculosis en los dos años precedentes.
11. Infección por hepatitis B o C crónica.
12. 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)

ORR, CR, CRi, PR, nodular PR, or PR with lymphocytosis, Response Criteria, with modification for treatment-related lymphocytosis

TRG,RC, RC, RCi, RP, RP nodular o una RP con linfocitosis, cristerios de respuesta respuesta con modificación para la linfocitosis relacionada con el tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

TEAEs and changes in safety laboratory values
OS defined as time from randomization to death
ORR defined as a CR,Cri, PR, nPR, or PR with lymphocytosis; hematologic improvements

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.
TRG definida como RC, RCi, RP, una RP nodular o una RP con linfocitosis, con modificación de la linfocitosis relacionada con el tratamiento.

E.5.2

Secondary end point(s)

TEAEs and changes in
laboratory values
DOR, defined as the time from
the date of the first confirmed response to the first documentation of relapse or PD, whichever occurs first for all subjects by treatment
arm
Evaluation of PFS, defined as the time
from the date of the first dose of study treatment to the first
documentation of PD or death due to any cause for all subjects by
treatment arm

AAST y cambios en los valores analíticos.
DdR, definida como el tiempo desde la fecha de la primera respuesta confirmada hasta la primera vez que se documenta la recidiva o la PE, lo que suceda primero para todos los pacientes por grupo de tratamiento.
Evaluación de la supervivencia sin progresión SSP, definida como el tiempo desde la fecha de la primera dosis del tratamiento del estudio hasta la primera vez que se documente la PE o la muerte por cualquier causa en todos los pacientes por grupo de 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

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)

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

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

Yes

E.8.1.7.1

Other trial design description

open label extension

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

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

Australia

Belgium

France

Germany

Hungary

Italy

Austria

New Zealand

Spain

United Kingdom

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:

302

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

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)

Standard of care

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	Completed

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