Clinical Trials Register

Summary
EudraCT Number:	2015-004033-28
Sponsor's Protocol Code Number:	IPI-145-22
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-04-11
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

Portugal - INFARMED

A.2

EudraCT number

2015-004033-28

A.3

Full title of the trial

A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination with Rituximab and Bendamustine vs Placebo Administered in Combination with Rituximab and Bendamustine in Subjects with Previously-Treated Indolent Non-Hodgkin Lymphoma

Estudo de fase 3, aleatorizado, em dupla ocultação, de duvelisib administrado em combinação com rituximab e bendamustina vs. placebo administrado em combinação com rituximab e bendamustina em doentes com linfoma não-Hodgkin indolente previamente tratado

A.3.1

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

A clinical trial which compares the safety and efficacy of chemotherapy (Rituximab and Bendamustine ) combined with Duvelisib, the study treatment, or a placebo in patients who have previously treated Indolent Non-Hodgkin Lymphoma.

Um ensaio clínico que compara a segurança e eficácia de quimioterapia (Rituximab e Bendamustina) combinada com o tratamento do estudo, Duvelisib, ou um placebo em doentes com Linfoma Não Hodgkin Indolente anteriormente tratado.

A.4.1

Sponsor's protocol code number

IPI-145-22

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02576275

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	Mary Kuskin
B.5.3	Address:
B.5.3.1	Street Address	784 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	1617-453-1394
B.5.6	E-mail	mary.kuskin@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/047/13
D.3 Description of the IMP
D.3.1	Product name	Duvelisib
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	Duvelisib
D.3.9.1	CAS number	1386861-48-9
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	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	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	Duvelisib
D.3.9.1	CAS number	1386861-48-9
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	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: 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	MabThera
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	MabThera
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	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.4	EV Substance Code	SUB12570MIG
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	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: 4
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	Levact
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Levact
D.3.4	Pharmaceutical form	Powder for 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	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
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	2.5
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.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	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Indolent Non-Hodgkin Lymphoma

Linfoma não-Hodgkin indolente

E.1.1.1

Medical condition in easily understood language

Indolent Non-Hodgkin Lymphoma

Linfoma não-Hodgkin indolente

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	18.1
E.1.2	Level	HLT
E.1.2	Classification code	10029621
E.1.2	Term	Non-Hodgkin's lymphomas unspecified histology indolent
E.1.2	System Organ Class	100000004851

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the efficacy of DBR vs PBR in subjects with previously-treated iNHL

Avaliar a eficácia de DBR vs. PBR em doentes com linfoma não-Hodgkin indolente previamente tratado

E.2.2

Secondary objectives of the trial

• Evaluate the safety of DBR and PBR in subjects with previously-treated iNHL
• Characterize the pharmacokinetics (PK) of duvelisib when administered with bendamustine and rituximab (BR) in subjects with previously-treated iNHL
Exploratory Objectives:
• Evaluate if biomarkers can predict clinical efficacy and/or safety of DBR vs PBR in subjects with previously-treated iNHL
• Evaluate Quality of Life (QoL) outcomes in subjects with previously-treated iNHL

• Avaliar a eficácia de DBR e PBR em doentes com linfoma não-Hodgkin indolente previamente tratado
• Caracterizar a farmacocinética (FC) do duvelisib quando administrado com bendamustina e rituximab (BR) em doentes com linfoma não-Hodgkin indolente previamente tratado
Objetivos exploratórios:
• Avaliar se os biomarcadores podem prever a eficácia clínica e/ou segurança de DBR vs. PBR em doentes com linfoma não-Hodgkin indolente previamente tratado
• Avaliar os resultados da Qualidade de vida (QoL) em doentes com linfoma não-Hodgkin indolente previamente tratado

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• ≥ 18 years of age
• Diagnosis of iNHL with one of the following histologic sub-types and grade:
- Follicular lymphoma (FL)Grade 1, 2, or 3a
- Small lymphocytic lymphoma (SLL)
- Marginal zone lymphoma (MZL)( splenic, nodal, or extranodal)
• Have received the following systemic treatments for iNHL:
- an anti-CD20 antibody; and
- chemotherapy
• At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT)/CT-PET or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (corresponds to Karnofsky Performance Status [(KPS) ≥60%])
For full inclusion criteria list, refer to protocol.

• ≥ 18 anos de idade
• Diagnóstico de linfoma não-Hodgkin indolente previamente tratado com um dos seguintes subtipos histológicos e grau:
- Linfoma Folicular: Grau 1, 2 ou 3a
- Linfoma linfocítico de pequenas células: Incluindo contagem absoluta de linfócitos (CAL) < 5.000 por mm3 no momento de diagnóstico ou seleção e sem antecedentes de leucemia linfocítica crónica (LLC)
- Linfoma da zona marginal (LZM): Esplénico, nodal ou extranodal
• Ter recebido os seguintes tratamentos sistémicos para linfoma não-Hodgkin indolente previamente tratado (iNHL):
- Um anticorpo anti-CD20; e
- Quimioterapia
• Pelo menos 1 lesão da doença mensurável > 1,5 cm em pelo menos uma dimensão medido por tomografia computorizada (TC)/TC-PET ou ressonância magnética (RM)
• Capacidade de desempenho ≤ 2 de acordo com a classificação do Eastern Cooperative Oncology Group (ECOG) (corresponde à Capacidade de Desempenho Karnofsky [(KPS) ≥ 60%])
Para a lista completa de critérios de inclusão, refira-se ao protocolo.

E.4

Principal exclusion criteria

• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
• Refractory to BR, defined as:
− Progression of disease while receiving or within 6 months of completing bendamustine + rituximab therapy
• Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
• Received prior allogeneic transplant
• Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
• Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• History of tuberculosis treatment within the two years prior to randomization
• History of chronic liver disease, veno-occlusive disease, or alcohol abuse
• Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
• Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
• Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
• Concurrent active malignancy other than adequately treated non-melanoma skin cancer or lentigo maligna without evidence of invasive disease or adequately treated carcinoma in situ without evidence of disease
• History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
For full exclusion criteria list, refer to protocol.

• Evidência clínica de transformação num subtipo mais agressivo de linfoma ou LF de grau 3B
• Refratário a BR, definido como:
- DP enquanto recebem terapia com bendamustina + rituximab ou nos 6 meses seguintes à conclusão dessa terapia
• Reação alérgica grave ou anafilática a qualquer terapia com anticorpos monoclonais, proteína murina ou hipersensibilidade conhecida a qualquer um dos medicamentos do estudo
• Receção anterior de transplante alogénico
• Receção de tratamento anterior com um inibidor de fosfoinositídeo-3-cinase (PI3K)
• Infeção por hepatite B, hepatite C ou vírus de imunodeficiência humana (VIH)
• Historial de tratamento para a tuberculose nos dois anos antes da aleatorização
• Historial de doença hepática crónica, doença veno-oclusiva ou abuso de substâncias alcoólicas
• Tratamento em curso com imunossupressores crónicos (por exemplo, ciclosporina) ou esteroides sistémicos > 20 mg de prednisona (ou o equivalente) diariamente (uma vez ao dia)
• Tratamento em curso para infeção bacteriana sistémica, fúngica ou viral no momento da seleção
• A impossibilidade de receber tratamento profilático para pneumocistose, vírus herpes simplex (VHS) ou herpes zoster (VZV) no momento da seleção
• Doença oncológica ativa concomitante que não o cancro da pele não melanoma adequadamente tratado, ou lentigo maligno sem evidência de doença invasiva, ou carcinoma cervical in situ adequadamente tratado sem evidência de doença.
• Historial de acidente vascular cerebral, angina instável, enfarte do miocárdio ou arritmia ventricular que requeira medicação ou a utilização de um pacemaker nos 6 meses anterioes à seleção
Para a lista completa de critérios de exclusão, refira-se ao protocolo.

E.5 End points

E.5.1

Primary end point(s)

Progression-Free Survival (PFS), defined as the time from randomization to documented progressive disease (PD) according to the revised International Working Group (IWG) criteria as assessed by the Independent Review Committee (IRC), or death due to any cause

Sobrevivência livre de progressão (SLP), definida como o período de tempo decorrido entre a distribuição aleatória até à doença progressiva (DP) documentada de acordo com os critérios revistos do Grupo de Trabalho Internacional (GTI) em conformidade com a avaliação da Comissão de Revisão Independente (CRI), ou morte devido a qualquer causa

E.5.1.1

Timepoint(s) of evaluation of this end point

From date of enrollment until the date of first documentation of progression or date of death from any cause, whatever came first, assessed up to 78 months

Desde a data de inclusão até à data da primeira documentação de progressão ou à data de morte por qualquer causa, o que acontecer primeiro, avaliado até 78 meses.

E.5.2

Secondary end point(s)

-Complete Response (CRR): Time Frame is every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.
-Overall Response Rate (ORR) : Time Frame is every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.
-Overall Survival (OS): Time Frame is every 6 months for up to 5 years from date of randomization.
-Duration of Response (DOR): Time Frame is every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.
-Safety (Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values) :Time Frame is Continuous from informed consent until 30 days from last dose
-Pharmacokinetics (PK): Time Frame is Cycle 1 and Cycle 2 (each cycle is 28 days)] to evaluate the Duvelisib concentration in plasma sample.
-Pharmacokinetics (PK): Time Frame is Cycle 1 and Cycle 2 (each cycle is 28 days)] to evaluate IPI-656 (metabolite) concentration in plasma sample.

-Resposta Completa (RC): A cada 3-6 ciclos (cada ciclo tem 28 dias) desde a data de aleatorização, até à data da primeira progressão documentada. Os doentes serão avaliados para progressão pela análise primária do estudo ou 5 anos após a aleatorização, o que ocorrer em último lugar.
- Taxa de Resposta Global (TRG): A cada 3-6 ciclos (cada ciclo tem 28 dias) desde a data de aleatorização, até à data da primeira progressão documentada. Os doentes serão avaliados para progressão pela análise primária do estudo ou 5 anos após a aleatorização, o que ocorrer em último lugar.
- Sobrevivência Global (SG): A cada 6 meses até 5 anos após a data de aleatorização.
- Duração da Resposta (DR): A cada 3-6 ciclos (cada ciclo tem 28 dias) desde a data de aleatorização, até à data da primeira progressão documentada. Os doentes serão avaliados para progressão pela análise primária do estudo ou 5 anos após a aleatorização, o que ocorrer em último lugar.
- Segurança (acontecimentos adversos emergentes do tratamento (AAET) e alterações nos valores laboratoriais de segurança): Continuamente, desde o consentimento informado até 30 dias após a última dose.
- Farmacocinética (PK): No ciclo 1 e ciclo 2 (cada ciclo tem 28 dias) para avaliar a concentração de Duvelisib na amostra de plasma.
- Farmacocinética (PK): No ciclo 1 e ciclo 2 (cada ciclo tem 28 dias) para avaliar a concentração de IPI-656 (metabolito) na amostra de plasma.

E.5.2.1

Timepoint(s) of evaluation of this end point

All timeframe are described in section E.5.2
-Complete Response (CRR)
-Overall Response Rate (ORR)
-Overall Survival (OS)
-Duration of Response (DOR)
-Safety (Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values)
-Pharmacokinetics (PK)

Todos os tempos estão descritos na secção E.5.2
- Resposta Completa (RC)
- Taxa de Resposta Global (TRG)
- Sobrevivência Global (SG)
- Duração da Resposta (DR)
- Segurança (acontecimentos adversos emergentes do tratamento (AAET) e alterações nos valores laboratoriais de segurança)
- Farmacocinética (PK)

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

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

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)

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

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

Argentina

Australia

Austria

Belarus

Belgium

Brazil

Bulgaria

Canada

China

Colombia

Czech Republic

Denmark

Ecuador

Egypt

Estonia

Finland

France

Georgia

Germany

Greece

Guatemala

Hong Kong

Hungary

Israel

Italy

Japan

Korea, Republic of

Latvia

Lebanon

Lithuania

Malaysia

Mexico

New Zealand

Panama

Peru

Philippines

Poland

Portugal

Romania

Russian Federation

Serbia

Singapore

Slovenia

South Africa

Spain

Taiwan

Thailand

Turkey

Ukraine

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

Última Visita do Último Doente (LPLV)

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:

420

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

230

F.4.2.2

In the whole clinical trial

600

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)

normal treatment - standard of care

tratamento normal – prática clínica

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

2016-04-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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