Clinical Trials Register

Summary
EudraCT Number:	2010-018960-17
Sponsor's Protocol Code Number:	TCD11419
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:	2010-04-20
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

2010-018960-17

A.3

Full title of the trial

"Estudio de fase II, abierto, aleatorizado para evaluar la eficacia y seguridad de paclitaxel administrado semanalmente como agente único y dos regímenes diferentes de SAR240550 (BSI-201), un inhibidor de PARP-1, en combinación con paclitaxel semanal, como terapia neoadyuvante en pacientes con cáncer de mama triple negativo en estadio II-IIIA (TNBC)"
__________________________________________________

Randomized, open-label, phase 2 study of the efficacy and safety of weekly paclitaxel single-agent and two different regimens of the PARP-1 inhibitor SAR240550 (BSI-201) in combination with weekly paclitaxel, as neoadjuvant therapy in patients with Stage II-IIIA triple negative breast cancer (TNBC)

A.3.2

Name or abbreviated title of the trial where available

SOLTI NEOPARP

A.4.1

Sponsor's protocol code number

TCD11419

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	sanofi-aventis recherche & développement
B.1.3.4	Country	France
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	Paclitaxel Ferrer Farma 6 mg/ml concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRER FARMA, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Concentrate 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	PACLITAXEL
D.3.9.3	Other descriptive name	PACLITAXEL
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	6
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

Neoadyuvante en pacientes con cáncer de mama triple negativo en estadio II-IIIA (TNBC)
_______________________________________________

Neoadjuvant TNBC

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10057654
E.1.2	Term	Breast cancer female

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 tasa de respuesta patológica completa (pCR) en la mama de pacientes tratadas en el Grupo A (SAR240550 dos veces por semana + paclitaxel semanal), el Grupo B (SAR240550 semanal + paclitaxel semanal), y el Grupo C (paclitaxel semanal como tratamiento de referencia en monoterapia).
__________________________________________________

Primary objective is to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinaisons: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.

E.2.2

Secondary objectives of the trial

- Tasa de pCR en la mama y la axila,
- Tasa de respuesta objetiva (ORR), tasa de conservación de la mama, supervivencia libre de enfermedad (SLE) y supervivencia global (SG), en cada grupo de tratamiento,
- Perfiles de seguridad de las combinaciones del estudio y del tratamiento de referencia en monoterapia,
- Características moleculares del tejido tumoral y cualquier correlación entre la actividad biológica del tratamiento del estudio y el desenlace de la enfermedad.

__________________________________________________

- pCR rate in the breast and axilla,
-Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
- Safety profiles of study combinations and of the single agent reference treatment,
- Molecular characteristics of the tumor tissue and any correlation between the biological activity of the study treatment and the disease outcome.

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

Subestudio biológico-molecular:
La caracterización del tejido tumoral y cualquier correlación entre la actividad biológica del tratamiento de estudio y el resultado de la enfermedad serán investigadas.

E.3

Principal inclusion criteria

I 01. Mujeres con edad superior 18 años.
I 02. Cáncer de mama invasivo en estadio II-IIIA confirmado histológicamente apto para cirugía definitiva y con receptores de estrógenos negativos y RPg negativos (para RE y RPg negativos: < 10% de tinción tumoral por inmunohistoquímica [IHC] o Allred < 5), y sin sobreexpresión de HER2 por IHC (0+, 1+) o hibridación in situ por fluorescencia (FISH) negativa (razón < 1,8) o IHC (2+, 3+)/FISH negativa.
I 03. El tumor primario debe tener un diámetro > 2 cm, es decir, estadio clínico T2-3, N0-2, M0, determinado a través de exploración física y mamografía (obligatoria) más ecografía mamaria o RMN. En caso de un tumor multifocal (focos tumorales ubicados en el mismo cuadrante), la lesión más grande debe ser > 2 cm y se designa como la lesión “diana” para todas las evaluaciones tumorales subsiguientes. El estado del cáncer de mama triple negativo se evaluará en dos de los focos incluido el más grande.
I 04. Estado funcional ECOG de 0 ó 1.
I 05. Los siguientes valores analíticos:
- Cifra absoluta de neutrófilos (CAN) superior o igual 1500/μl y cifra de plaquetas superior o igual 100 000/μl.
- Hemoglobina superior o igual 9 g/dl.
- Bilirrubina sérica H 1,0 veces el límite superior de la normalidad (LSN) o bilirrubina < 1,5 LSN por síndrome de Gilbert
- Alanina-aminotransferasa (ALT) y aspartato-aminotransferasa
(AST) H 2,5 x LSN.
- Fosfatasa alcalina H 2,5 x LSN.
- Creatinina sérica H 1,5 mg/dl o aclaramiento de creatinina calculado superior o igual 60 ml/m.
I 06. Capacidad y disposición para cumplir con las visitas del estudio, el tratamiento, las pruebas y el protocolo.
I 07. Pacientes que acceden a que se recojan sus muestras tumorales en situación basal y en el momento de la cirugía definitiva y a que se envíen al laboratorio central para confirmación del estado del cáncer de mama triple negativo en situación basal y subestudio biológicomolecular como parte de este protocolo.
I 08. Consentimiento informado por escrito.

E.4

Principal exclusion criteria

E 01. Cualquier tratamiento previo del cáncer de mama primario.
E 02. Cáncer de mama metastásico, localmente avanzado o inflamatorio.
E 03. Cáncer de mama multicéntrico.
E 04. Cáncer de mama bilateral concomitante o antecedentes de cáncer de mama contralateral.
E 05. Enfermedad por úlcera péptica activa, diabetes no controlada, o trastorno convulsivo no controlado.
E 06. Hipertensión no controlada (sistólica > 150 mmHg y/o diastólica > 100 mmHg).
E 07. Enfermedad cardiovascular clínicamente significativa (es decir, activa), incluyendo accidente cerebrovascular (H 6 meses antes de la inclusión), infarto de miocardio (H 6 meses antes de la inclusión), angina de pecho inestable,
insuficiencia cardíaca congestiva de grado O 2 según la New York Heart Association (NYHA), arritmia cardíaca grave que requiere medicación durante el estudio y que podría interferir con la regularidad del tratamiento del estudio, o no controlada con la medicación.
E 08. Infección conocida por el virus de la inmunodeficiencia humana (VIH) u otra infección grave o activa que requiera antibióticos i.v. en la aleatorización.
E 09. Mujeres embarazadas o en periodo de lactancia.
E 10. Mujeres en edad fértil (< 2 años después de la última menstruación) que no utilicen medios anticonceptivos eficaces y no hormonales (dispositivo intrauterino, anticonceptivo de barrera acompañado de espermicida o esterilización quirúrgica) durante el estudio y durante los 6 meses siguientes a la última administración del fármaco del estudio.
E 11. Administración de cualquier vacuna con virus vivo atenuado en las 8 semanas anteriores a la entrada en el estudio.
E 12. Uso de cualquier fármaco experimental en los 30 días anteriores a la administración de la primera dosis de fármaco del estudio o tratamiento simultáneo en otro estudio clínico.
E 13. Necesidad de radioterapia simultáneamente con el tratamiento antineoplásico del estudio. Se consideran aptas a las pacientes que requieren radioterapia en la mama o la pared torácica después de cirugía.
E 14. Hipersensibilidad conocida a cualquiera de los fármacos del estudio o a los excipientes.
E 15. Alergia a cromóforos.
E 16. Enfermedades importantes que podrían afectar a la participación en el estudio (p. ej., disfunción pulmonar, renal o hepática no controlada, infección no controlada).
E 17. Incapacidad o negativa a seguir el protocolo del estudio o cooperar plenamente con el investigador o su representante designado.
Se requiere la confirmación de los criterios de elegibilidad (especialmente el estado del cáncer de mama triple negativo confirmado a través de revisión central) para todas las pacientes potenciales del estudio ANTES de la aleatorización.

E.5 End points

E.5.1

Primary end point(s)

Se calcularán las tasas de pCR con su IC del 95% sobre la base de la población ITT y se confirmarán a través de revisión central por parte de expertos independientes. Las pacientes no evaluables se considerarán no respondedoras.
__________________________________________________

pCR rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by independent blinded centralized review.

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

Yes

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

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)

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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	No
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	90
F.4.2	For a multinational trial
F.4.2.1	In the EEA	135

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

2010-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-06-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-02-28

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