Clinical Trials Register

Summary
EudraCT Number:	2010-019255-22
Sponsor's Protocol Code Number:	EFC11553
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:	2010-09-02
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

2010-019255-22

A.3

Full title of the trial

Ensayo aleatorizado de Fase III de gemcitabina/carboplatino con o sin BSI-201 (SAR240550) (un inhibidor de PARP1) en pacientes con cáncer de pulmón no microcítico (CPNM) epidermoide en estadío IV no tratado previamente
__________________________________________________

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)

A.4.1

Sponsor's protocol code number

EFC11553

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BiPar Sciences, 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	SAR240550 (BSI-201)
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	SAR240550 (BSI-201)
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	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Gemzar 200mg powder for solution for infusion, Gemzar 1g powder for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Lilly Deutschland 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.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GEMCITABINE HYDROCHLORIDE
D.3.9.1	CAS number	122111-03-9
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	1000
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	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	Carboplatin 10 mg/ml Intravenous Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK Ltd
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	carboplatin
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	41575-94-4
D.3.9.3	Other descriptive name	CARBOPLATIN
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	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

cáncer de pulmón no microcítico
_______________________________________

Squamous Non Small Cell Lung Cancer

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	PT
E.1.2	Classification code	10029522
E.1.2	Term	Non-small cell lung cancer stage IV

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la supervivencia global (SG) de los pacientes con CPNM epidermoide en estadío IV que reciben gemcitabina/carboplatino con o sin BSI-201.
______________________________________________

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without BSI-201.

E.2.2

Secondary objectives of the trial

Los objetivos secundarios de este estudio son evaluar lo siguiente en los pacientes con CPNM epidermoide en estadío IV que reciben gemcitabina/carboplatino con o sin BSI-201:
- Supervivencia sin progresión (SSP)
- Tiempo hasta la progresión (THP)
- Tasa de respuesta objetiva (TRO)
- Seguridad y tolerabilidad de la pauta de tratamiento
- Calidad de vida determinada mediante EORTC QLQ-30 y QLQ-LC13
_________________________________________________

To evaluate the following in patients with advanced squamous cell lung cancer receiving gemcitabine/carboplatin either with or without BSI-201:
?Progression free survival (PFS)
?Time to progression (TTP)
?Objective response rate (ORR)
?Safety and tolerability of the treatment regimen
?Quality of life as measured by EORTC QLQ-30 and QLQ-LC13

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

El objetivo del subestudio es evaluar potenciales marcadores biológicos para la predecir la eficacia del tratamiento. Se recogerán muestras de sangre y de tejido para el análisis genético del ADN y/o ARN.
______________________________________________

The objective of the study is to evaluate potential biomarkers for predicting treatment efficacy. Blood samples and tumor tissue will also be collected for DNA and/or RNA genetic testing.

E.3

Principal inclusion criteria

Los pacientes elegibles deben cumplir los siguientes criterios para ser incluidos en el estudio:
1. CPNM epidermoide en estadío IV de nuevo diagnóstico. Esto incluye a los pacientes que se presentan con metástasis diseminadas, y a aquellos con derrame pleural o pericárdico neoplásico (o sea, anterior estadío IIIB del 6º sistema de estadiaje TNM).
2. Pacientes que han recibido terapia adyuvante previa para el cáncer de pulmón en estadío precoz si han transcurrido al menos 12 meses desde dicho tratamiento.
3. Carcinoma broncogénico epidermoide confirmado histológicamente. Los pacientes cuyos tumores contienen histologías no microcíticas mixtas son elegibles mientras el carcinoma epidermoide sea la histología predominante. Los tumores mixtos con elementos anaplásicos microcíticos no son elegibles. Las muestras citológicas obtenidas mediante cepillado, lavado o aspiración con aguja de la lesión definida son aceptables.
4. Los pacientes con radioterapia previa como terapia definitiva para el cáncer de pulmón no microcítico localmente avanzado son elegibles mientras que la recidiva esté fuera del campo de la radioterapia original. La radioterapia debe haberse finalizado >4 semanas antes de la fecha de la firma del Consentimiento Informado.
5. Presencia de enfermedad evaluable (medible o no medible).
6. Estado Funcional ECOG de 0 o 1 (véase el Apéndice A).
7. Siguientes valores de laboratorio:
• Recuento absoluto de neutrófilos (ANC) >1,500/microL y plaquetas >100,000/microL (≤72 horas antes del tratamiento inicial).
• Hemoglobina >9 g/dl (Nota: Los pacientes pueden recibir transfusiones o eritropoyetina para mantener o superar este nivel).
• Bilirrubina < LSN.
• Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ≤2,5 veces el límite superior normal si no hay afectación hepática o ≤5 veces el límite superior normal si hay afectación hepática.
• Creatinina <2,0 mg/dl o aclaramiento de creatinina >40 ml/min (calculado mediante el método de Cockcroft-Gault (véase la Sección 8.3.3).
8. Las mujeres potencialmente fértiles deben tener una prueba de embarazo en suero negativa realizada en los 7 días previos al comienzo del tratamiento. Las mujeres potencialmente fértiles o los hombres con parejas potencialmente fértiles deben usar medidas de control de natalidad efectivas durante el tratamiento y al menos 3 meses tras la última dosis del tratamiento del estudio. Si una mujer se queda embarazada o sospecha que está embarazada mientras está participando en este estudio, debe acceder a informar inmediatamente al médico que la trata.
9. >18 años de edad.
10. Capacidad para comprender la naturaleza de este estudio, otorgar el consentimiento informado por escrito y cumplir con los requisitos del estudio.
11. Los pacientes incluidos en este estudio deben estar dispuestos a proporcionar tejido de una biopsia previa del tumor (si está disponible) para análisis correlativo. Un paciente será elegible para su inclusión en el estudio aunque el tejido no esté disponible.

E.4

Principal exclusion criteria

Los pacientes elegibles no deben tener los siguientes criterios para ser incluidos en el estudio:
1. Tratamiento previo con gemcitabina, carboplatino (excepto como terapia adyuvante) o BSI 201.
2. Historia pasada o actual de neoplasia aparte del diagnóstico de inclusión, excepto cáncer cutáneo no melanoma o carcinoma in-situ del cuello uterino tratados, u otros cánceres curados mediante terapia local sólo y con una supervivencia sin enfermedad de >5 años.
3. Historia de enfermedad cardiaca, definida por:
- Hipertensión maligna
- Angina inestable
- Insuficiencia cardiaca congestiva
- Infarto de miocardio en los 6 meses previos
- Arritmias cardiacas sintomáticas
4. Metástasis cerebrales activas. Los pacientes con metástasis cerebrales tratadas son elegibles si (1) la radioterapia se finalizó al menos 2 semanas antes de la inclusión en el estudio; (2) las pruebas radiológicas de seguimiento no muestran progresión de la enfermedad; y (3) el paciente no necesita esteroides.
5. Mujeres embarazadas o dando lactancia materna.
6. Cualquier infección activa grave (> grado 2) en el momento del tratamiento.
7. Trastorno médico subyacente que afectaría a la capacidad del paciente para recibir el tratamiento del protocolo.
8. Procedimiento quirúrgico mayor, biopsia abierta o lesión traumática ≤28 días antes del comienzo del tratamiento, o previsión de la necesidad de cirugía mayor durante el transcurso del estudio.
9. Enfermedad no controlada o intercurrente incluyendo, entre otras, infección activa o continuada, insuficiencia cardiaca congestiva sintomática, angina de pecho inestable o arritmia cardiaca.
10. Historia de cualquier trastorno médico o psiquiátrico o alteración de laboratorio que, según la opinión del investigador, pueda aumentar los riesgos asociados con la participación en el estudio o con la administración de los productos en investigación, o que pueda interferir con la interpretación de los resultados.
11. Alergia/hipersensibilidad conocida o sospechada a cualquier fármaco administrado en el transcurso de este ensayo.

E.5 End points

E.5.1

Primary end point(s)

supervivencia global (SG)
____________________________

Overall survival (OS)

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

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	95
F.4.2	For a multinational trial
F.4.2.1	In the EEA	265
F.4.2.2	In the whole clinical trial	825

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

2010-11-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-04-11

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Orphan Designation Number:
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