Clinical Trials Register

Summary
EudraCT Number:	2015-002057-35
Sponsor's Protocol Code Number:	ZIN-130-1504
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:	2015-10-26
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

2015-002057-35

A.3

Full title of the trial

A Phase 1-2 ascending dose study to assess the pharmacodynamics, pharmacokinetics, and safety of HSP 130 in subjects with non metastatic breast cancer following single dose and multiple dose administration by subcutaneous injection

Estudio de dosis ascendentes de fase 1-2 para evaluar la farmacodinámica, farmacocinética y seguridad del HSP 130 en pacientes con cáncer de mama no metastásico tras la administración de una o varias dosis mediante inyección subcutánea.

A.3.1

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

A study of the safety and effects of one or more doses of HSP-130 injected under the skin in patients with breast cancer that has not spread to distant sites in the body

Estudio de seguridad y eficacia de HSP-130 en pacientes diagnosticados de cancer de mama no metastásico tras la administración de una o varias inyecciones bajo la piel.

A.4.1

Sponsor's protocol code number

ZIN-130-1504

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	Hospira, 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	Hospira 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	Biorasi LLC
B.5.2	Functional name of contact point	European Project Operations
B.5.3	Address:
B.5.3.1	Street Address	Niermannsweg 11
B.5.3.2	Town/ city	Erkrath
B.5.3.3	Post code	40699
B.5.3.4	Country	Germany
B.5.4	Telephone number	00491706392620
B.5.5	Fax number	+4921125033233
B.5.6	E-mail	hschmied@biorasi.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	HSP-130
D.3.2	Product code	HSP-130
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	208265-92-3
D.3.9.2	Current sponsor code	HSP-130
D.3.9.3	Other descriptive name	Pegylated filgrastim
D.3.9.4	EV Substance Code	SUB16451MIG
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	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	208265-92-3
D.3.9.2	Current sponsor code	HSP-130
D.3.9.3	Other descriptive name	Pegylated filgrastim
D.3.9.4	EV Substance Code	SUB16451MIG
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	6
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	Yes
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	Yes
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

Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Reducción de la duración de la neutropenia y de la incidencia de neutropenia febril en pacientes adultos con tumores malignos tratados con quimioterapia citotóxica (con excepción de leucemia mieloide crónica y síndromes mielodisplásicos).

E.1.1.1

Medical condition in easily understood language

Purpose is to lower the chance of getting fever or infection in patients with cancer who are getting a chemotherapy that can lower the number of white blood cells.

Indicado para reducir las probabilidades de aparición de fiebre o infecciones en pacientes con cancer tratados con quimioterapia que puede provocar una disminución de los glóbulos blancos.

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	LLT
E.1.2	Classification code	10021456
E.1.2	Term	Immunodeficiency secondary to oncology chemotherapy
E.1.2	System Organ Class	100000004870

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Cycle 0:
To characterize the pharmacodynamic (PD) response of absolute neutrophil count (ANC) and CD34+ count to HSP 130 at doses of 3 mg and 6 mg when administered as a single subcutaneous (SC) dose without chemotherapy to determine whether it is appropriate to study multiple doses of 3 mg with the context of background chemotherapy.
Cycles 1 - 4:
To characterize the PD response of duration of severe neutropenia (DSN) in Cycle 1 to HSP 130 over a range of doses when administered as single and multiple SC doses.

Ciclo 0:
Caracterizar la respuesta farmacodinámica (FD) de la cifra absoluta de neutrófilos (CAN) y la cifra de CD34+ al HSP 130 a dosis de 3 mg y 6 mg administrado en una única dosis subcutánea (s.c.) sin quimioterapia para determinar si es apropiado estudiar varias dosis de 3 mg en el contexto de la quimioterapia de base.

Ciclos 1-4:

Caracterizar la respuesta FD del tiempo de evolución de la neutropenia grave (TENG) en el ciclo 1 al HSP 130 a diversas dosis administrado en una o varias dosis s.c.

E.2.2

Secondary objectives of the trial

Cycle 0:
To characterize the pharmacokinetics (PK) of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC injection without background chemotherapy.
To characterize the safety of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC dose without background chemotherapy.

Cycles 1 - 4:
To characterize the PD response of ANC to HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses.
To characterize the PK of HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses.
To characterize the safety of HSP 130 over a range of doses when administered as single and multiple SC doses.

Ciclo 0:
?Caracterizar la farmacocinética (FC) del HSP 130 a dosis de 3 mg y 6 mg administradas en una única inyección s.c. sin quimioterapia de base.
?Caracterizar la seguridad del HSP 130 a dosis de 3 mg y 6 mg administrado en una única dosis s.c. sin quimioterapia de base.

Ciclos 1-4:
Caracterizar la respuesta FD de la CAN al HSP 130 en los ciclos 1 y 4 y a diversas dosis administrado en una o varias dosis s.c.c.
Caracterizar la FC del HSP 130 en los ciclos 1 y 4 a diversas dosis administrado en una o varias dosis s.c.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics Committee (IEC) prior to any study related activities
2. Females ? 18 years
3. Histologically confirmed and documented invasive breast cancer
4. Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up
5. Chemotherapy naïve, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide based regimen, e.g., TAC or TC as background chemotherapy
6. Zubrod performance status ? 2
7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
a. Hemoglobin ? 10 mg/dL
b. ANC ? 1.5 x 109/L
c. Platelet count of ? 100 x 109/L
d. Total bilirubin ? 2 mg/dL
e. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ? 3 x the upper limit of normal (ULN) of the reference lab
f. Serum creatinine of ? 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ? 60 mg/min
8. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status.
9. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study

1.Ha sido informada, se le ha dado tiempo y oportunidad suficiente para leer la información sobre la participación en el estudio y ha firmado y fechado el formulario de consentimiento informado aprobado por un comité de ética de investigación clínica (CEIC) antes de llevar a cabo ninguna actividad relacionada con el estudio
2.Mujeres ? 18 años
3.Cáncer de mama invasivo confirmado histológicamente y documentado
4.Cáncer de mama sin indicios de metástasis distantes (estadio 4) según las pruebas para la determinación de la fase
5.No ha recibido quimioterapia previamente, no ha recibido quimioterapia neoadyuvante y es candidata para recibir quimioterapia adyuvante con una pauta con taxano/ciclofosfamida, p. ej., TAC o TC como quimioterapia de base
6.Estado funcional Zubrod ? 2
7.Reserva funcional medular, hepática y renal adecuada demostrada por:
a.Hemoglobina ? 10 mg/dl
b.CAN ? 1,5 x 109/l
c.Cifra de trombocitos ? 100 x 109/l
d.Bilirrubina total ? 2 mg/dl
e.Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ? 3 veces el límite superior de lo normal (LSN) del laboratorio de referencia
f.Creatinina sérica ? 1,5 veces el LSN del laboratorio de referencia o índice de filtración glomerular estimado (IFGe) ? 60 mg/min
8.Las pacientes en edad fértil y sus parejas acceden a evitar el embarazo mientras dure el estudio (hasta la visita de seguimiento). El método conceptivo concreto deberá comentarse con el oncólogo responsable y ser considerado aceptable por este en el contexto de la situación de los receptores hormonales tumorales;
9.Es capaz de entender las instrucciones verbales o escritas, cumplir todos los requisitos del estudio y comunicarse eficazmente con el personal del estudio y está disponible durante la duración prevista del estudio

E.4

Principal exclusion criteria

1. Previous granulocyte colony stimulating factor (G CSF) exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM CSF), or any other branded or biosimilar G CSF
2. Prior autologous stem cell harvest of any type
3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to Escherichia coli (E. coli) derived proteins, filgrastim, other G CSFs, or pegylated agents
4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
5. Chemotherapy other than that included in this study (i.e., taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP 130, prior bone marrow or stem cell transplantation, or malignancy within 5 years
6. Known HER2+ (overexpressing breast cancer)
7. Known triple negative (estrogen receptor negative, progesterone receptor negative and HER2 negative) breast cancer
8. Medical conditions including but not limited to: Known sickle cell disease; known severe persistent drug induced myelosuppression; severe uncontrolled cardiac disease; any malignancy other than breast with the exception of adequately treated squamous or basal cell carcinoma or the skin or cervical carcinoma in situ within 5 years; pregnancy or lactation; received live, live attenuated, or non live vaccine within 4 weeks
9. Current or recent treatment (within 30 days before the first administration of the HSP 130) with any other Investigational Medicinal Product
10. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP 130, or patient is high risk for treatment complication

1.Exposición previa a un factor estimulante de las colonias de granulocitos (G-CAFÉ), incluidos filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, factor estimulante de las colonias de granulocitos-macrófagos (GM-CSF) u otro G-CSF de marca o biosimilar
2.Extracción previa de células madre autólogas de cualquier tipo
3.Sensibilidad a fármacos, reacción alérgica o hipersensibilidad conocida o reacción idiosincrática a proteínas derivadas de Escherichia (E. coli), filgrastim, otros G-CSF o fármacos pegilados
4.Hipersensibilidad conocida al docetaxel, el polisorbato 80 o la doxorrubicina
5.Quimioterapia distinta de la incluida en este estudio (es decir, pauta con taxano/ciclofosfamida, p. ej., TAC o TC) quimioterapia neoadyuvante; fármacos inmunodepresores conocidos, incluido el uso prolongado de corticoesteroides orales, radioterapia en las 4 semanas previas a la primera dosis de HSP 130, antes de trasplante de médula ósea o células madre, o cáncer en los 5 últimos años
6.HER2+ conocido (que sobreexpresa cáncer de mama)
7.Cáncer de mama triple negativo conocido (receptor de estrógenos negativo, receptor de progesterona negativo y HER2 negativo)
8.Afecciones médicas que incluyen, entre otras: Drepanocitosis conocida, mielosupresión medicamentosa persistente grave conocida; cardiopatía no controlada grave según se define en la sección 4.3; cualquier cáncer distinto del de mama, con excepción del carcinoma escamocelular o basocelular tratado adecuadamente o el carcinoma cutáneo o cervical in situ en los 5 últimos años; embarazo o lactancia; vacuna con microorganismos vivos, atenuados o inactivos en las 4 últimas semanas
9.ratamiento actual o reciente (en los 30 días previos a la primera administración de HSP 130) con cualquier otro medicamento en investigación
10.La paciente presenta indicios de otra enfermedad o trastorno médico o psicológico concomitante, disfunción metabólica, hallazgo de la exploración física o prueba analítica que lleve a sospechar la presencia de una enfermedad o un trastorno que contraindique el uso de un HSP 130, o alto riesgo de complicaciones del tratamiento

E.5 End points

E.5.1

Primary end point(s)

Pharmacodynamic Endpoints:
Cycle 0:
? Primary Variable: Area under the effect curve for ANC (AUECANC)
? Secondary Variables: Maximum effect for ANC (ANC_Emax), time of maximum effect for ANC (ANC Tmax), area under the effect curve for CD34+ (AUECCD34+), maximum effect for CD34+ count (CD34+_Emax), time of maximum effect for CD34+ count (CD34+ Tmax)

Cycles 1 - 4:
? Primary Variable: Duration of severe neutropenia (DSN). DSN is defined as days with grade 4 neutropenia (ANC < 0.5 x 109/L) in Cycle 1
? Secondary Variables: DSN in Cycle 4. ANC nadir concentration, time of nadir concentration, area under the effect curve (AUEC), incidence of FN, defined as tympanic or axillary body temperature > 38°C for > 1 hour with ANC < 1.0 x 109/L, incidence of severe neutropenia (grade 4, ANC < 0.5 x 109/L) and time to ANC recovery (the first day with ANC ? 2.0 x 109/L after any day with ANC < 2.0 x 109/L) in Cycle 1 and Cycle 4

Variables farmacofinamicas
Ciclo 0:
Variable principal: Área bajo la curva del efecto para la CAN (ABCECAN),
Variables secundarias: Efecto máximo en la CAN (CAN_Emáx), momento del efecto máximo en la CAN (CAN Tmáx), área bajo la curva del efecto en los CD34+ (ABCECD34+), efecto máximo en la cifra de CD34+ (CD34+_Emáx), momento del efecto máximo en la cifra de CD34+ (CD34+ Tmáx)

Ciclos 1-4
Variable principal: Tiempo de evolución de la neutropenia grave (TENG). El TENG se define como los días con neutropenia de grado 4 (CAN < 0,5 x 109/l) en el ciclo 1.
Variables secundarias: Tiempo de evolución de la neutropenia grave (TENG) en el ciclo 4. Concentración mínima de la CAN, momento de la concentración mínima, área bajo la curva del efecto (ABCE), incidencia de NF, definida como temperatura corporal timpánica o axilar > 38,5 ºC durante > 1 hora con CAN < 1,0 x 109/l, incidencia de neutropenia grave (grado 4, CAN < 0,5 x 109/l) y momento de la recuperación de la CAN (el primer día con CAN ? 2,0 x 109/l después de un día con CAN < 2,0 x 109/l) en el ciclo 1 y el ciclo 4.

E.5.1.1

Timepoint(s) of evaluation of this end point

Cycle 0:
Pharmacodynamic sampling for absolute neutrophil count (ANC), CD34+ count will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose

Cycles 1 - 4
Pharmacodynamic sampling for absolute neutrophil count (ANC) will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only

Ciclo 0:
Las muestras de sangre para la determinación de la CAN y la cifra de CD34+ se extraerán en la hora previa a la administración y 48, 96, 144, 192, 240 y 312 horas después de la dosis.

Ciclos 1-4:

Las muestras de sangre para la determinación de la CAN se extraerán en la hora previa a la administración y 48, 96, 144, 192, 240 y 312 horas después de la dosis. Este calendario de recogida de muestras se aplicará en los ciclos 1 y 4.

E.5.2

Secondary end point(s)

Pharmacokinetic Endpoints:
Cycle 0:
?Primary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to time infinity (AUC0 ?) and the maximum observed serum HSP 130 concentration (Cmax)
?Secondary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to the time of last measurable concentration (AUC0 t), the time of maximum serum HSP 130 concentration (Tmax), elimination half life (t1/2), elimination rate constant (?z), and apparent clearance (CL)

Cycles 1?4:
?Primary Variables: AUC 0-t and Cmax
?Secondary Variables: AUC 0-?, Tmax, t1/2, ?z, and CL

Variables farmacocinéticas:
Ciclo 0:
Variables principales: Área bajo la curva de HSP 130 sérico y tiempo desde el momento de administración de la dosis hasta el momento infinito (ABC0 ?) y la concentración de HSP 130 sérico máxima observada (Cmáx)
Variables secundarias: Área bajo la curva de HSP 130 sérico y tiempo desde el momento de administración de la dosis hasta el momento de la última concentración mensurable (ABC0 t), el momento de la concentración de HSP 130 sérico máxima (Tmáx), la semivida de eliminación (t1/2), la constante de la tasa de eliminación (?z) y el aclaramiento aparente (ACL)

Ciclos 1-4
Variables principales: ABC0 t y Cmáx
Variables secundarias: ABC0 ?, Tmáx, t1/2, ?z y ACL

E.5.2.1

Timepoint(s) of evaluation of this end point

Cycle 0:
Pharmacokinetic sampling will be collected within 1 hour prior to dose at Day 1, and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose

Cycles 1 - 4
Pharmacokinetic sampling will be collected within 1 hour prior to dose and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only

Ciclo 0:

Las muestras de sangre se extraerán en la hora previa a la administración de la dosis del día 1 y 6, 12, 24, 48, 96, 144, 192, 240 y 312 horas después de la dosis.

Ciclos 1 y 4

Las muestras de sangre se extraerán en la hora previa a la administración de la dosis del día 2 y 6, 12, 24, 48, 96, 144, 192, 240 y 312 horas después de la dosis en los ciclos 1 y 4 únicamente.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

Yes

E.7.1.1

First administration to humans

Yes

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)

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

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

The end of study is defined as the day the last subject completes the Follow up Visit, 30 days after last dose of HSP 130, in Cycle 4 or is discontinued

El final de estudio se define como el día en que el último paciente atiende a la ultima visita de seguimiento (que se producirá 30 días después de la administración de HSP-130 en cuarto ciclo o si se decide discontinuar al paciente del estudio).

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

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:

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

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

F.4.2.2

In the whole clinical trial

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)

Cycle 0:
Sponsor will reimburse investigator for use of EU-approved Neulasta for patients who received HSP-130 in the Cycle 0 part of the study.
Cycles 1-4:
Following study end the patients will receive care as determined by their treating physician.

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

2015-12-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-05

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