Clinical Trials Register

Summary
EudraCT Number:	2014-001408-23
Sponsor's Protocol Code Number:	ABI-007-PANC-007
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:	2015-01-16
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

2014-001408-23

A.3

Full title of the trial

NAB-PACLITAXEL (ABRAXANE®) PLUS GEMCITABINE IN SUBJECTS WITH LOCALLY ADVANCED PANCREATIC CANCER (LAPC): AN INTERNATIONAL, OPEN-LABEL, MULTI-CENTER, PHASE 2 STUDY (LAPACT)

NAB-PACLITAXEL (ABRAXANE®) MÁS GEMCITABINA EN SUJETOS CON CÁNCER PANCREÁTICO LOCALMENTE AVANZADO (CPLA): ESTUDIO DE FASE 2, INTERNACIONAL, ABIERTO Y MULTICÉNTRICO (LAPACT)

A.3.1

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

TRIAL OF ABRAXANE AND GEMCITABINE TO TREATMENT PANCREATIC CANCER PATIENTS WHO CAN NOT HAVE SURGERY BECAUSE OF CANCER LOCATION

ENSAYO DE ABRAXANE Y GEMCITABINA PARA EL TRATAMIENTO DE PACIENTES CON CÁNCER DE PÁNCREAS QUE NO PUEDEN SOMETERSE A CIRUGÍA DEBIDO A LA LOCALIZACIÓN DEL CÁNCER

A.3.2

Name or abbreviated title of the trial where available

LAPACT

A.4.1

Sponsor's protocol code number

ABI-007-PANC-007

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	Celgene Corporation
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	Celgene Corporation
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	Celgene Corporation
B.5.2	Functional name of contact point	ClinicalTrialDisclosure
B.5.3	Address:
B.5.3.1	Street Address	9225 Indian Creek Parkway, Suite 900
B.5.3.2	Town/ city	Overland Park, Kansas
B.5.3.3	Post code	66210
B.5.3.4	Country	United States
B.5.4	Telephone number	+34914229000
B.5.5	Fax number	+19132660394
B.5.6	E-mail	ClinicalTrialDisclosure@celgene.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	Yes
D.2.1.1.1	Trade name	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe 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.3.4	Pharmaceutical form	Powder for suspension for injection
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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	ABI-007
D.3.9.4	EV Substance Code	SUB09583MIG
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	100
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	Yes
D.3.11.13.1	Other medicinal product type	IMP contiene un excipiente de origen biológico,albúmina,agente estabilizador no activo.Derivado de sangre humana de sujeto para selección de donantes aprobados y procesos de fabricación de productos
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	Gemcitabine for Injection 1g
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited, Middlesex (UK)
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.3.2	Product code	L01BC05
D.3.4	Pharmaceutical form	Powder 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	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.4	EV Substance Code	SUB07892MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Locally advanced pancreatic cancer

Cáncer pancreático localmente avanzado

E.1.1.1

Medical condition in easily understood language

Locally Advanced Pancreatic Cancer

Cáncer pancreático localmente avanzado

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10033606
E.1.2	Term	Pancreatic cancer non-resectable
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the time to treatment failure in LAPC subjects treated with nab-paclitaxel plus gemcitabine as induction therapy followed by Investigator?s Choice of treatment

Evaluar el tiempo transcurrido hasta el fracaso en el tratamiento (TFT) en sujetos con
CPLA tratados con nab-paclitaxel más gemcitabina a modo de inducción seguido de
un tratamiento a elección del investigador

E.2.2

Secondary objectives of the trial

-To evaluate the disease control rate (DCR) after the first 6 cycles of nab-paclitaxel
plus gemcitabine
-To evaluate the overall response rate (ORR)
-To evaluate the overall progression-free survival (PFS) and overall survival (OS)
-To assess the overall safety profile
-To evaluate the subject?s health-related quality of life (QoL)

- Evaluar la tasa de control de la enfermedad (TCE) tras los 6 primeros ciclos de
nab-paclitaxel más gemcitabina.
- Evaluar la tasa de respuesta global (TRG).
- Evaluar la supervivencia sin progresión (SSP) y la supervivencia global (SG).
- Evaluar el perfil de seguridad global.
- Evaluar la calidad de vida (CdV) relacionada con la salud del sujeto.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
?No prior anticancer therapy for pancreatic cancer
?? 18 years of age with a performance status of 0 or 1
?Adequate complete blood counts, hepatic function, and renal function
?Signed informed Consent

- Adenocarcinoma de páncreas confirmado histológica o citológicamente
- Ningún tratamiento previo para el cáncer pancreático
- Edad mínima de 18 años con estado funcional del ECOG de 0 o 1
- Parámetros de recuentos completos de sangre, función hepática y función renal adecuados
- Documentos de Consentimiento Informado firmado

E.4

Principal exclusion criteria

?Active bacterial, viral, or fungal infection
?Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
?Subjects with sensory neuropathy, ascites, or plastic biliary stent.
?Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
?Women who are pregnant or breast feeding

- Infección bacteriana, micótica o vírica activa
- Infección conocida por el virus de la hepatitis B o C o antecedentes de infección por el
virus de la inmunodeficiencia humana (VIH), tratamiento con inmunodepresores o
mielodepresores
- Factores de riesgo médicos graves relacionados con cualquiera de los sistemas orgánicos
principales o trastornos psiquiátricos graves que podrían poner en peligro la seguridad del
sujeto o la integridad de los datos del estudio (incluyendo, pero no limitando: transtorno del tejido conjuntivo, enfermedad pulmonar, y desórdenes cardiacos o convulsivos)
- Embarazo o lactancia

E.5 End points

E.5.1

Primary end point(s)

Time to treatment failure

Tiempo hasta el fracaso del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

Time after the first dose of study therapy to treatment failure

Tiempo transcurrido entre la primera dosis del tratamiento del estudio y el fracaso del tratamiento.

E.5.2

Secondary end point(s)

Secondary efficacy endpoints:
1. DCR after 6 cycles of nab-paclitaxel plus gemcitabine
2. ORR
3. PFS
4. OS
5. differences in outcomes from baseline

Secondary safety endpoint:
- incidence of treatment-emergent AEs, SAEs, laboratory abnormalities and other safety parameters

1 TCE después de 6 ciclos de nab-paclitaxel más gemcitabina
2 TRG
3 SSP
4 SG
5 Diferencias en cuanto a resultados con respecto al momento basal

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary efficacy endpoints:
1. defined as the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit
2. defined as the combined incidence of CR and PR
3. defined as the time after the first dose of study therapy to disease progression or death (by any cause)
4. defined as the time after the first dose of study therapy to death (by any cause)
5. during treatment, and after treatment with nab-paclitaxel plus gemcitabine for the EORTC quality of life questionnaires, EORTC QLQC30 and QLQ-PAN26

Secondary safety endpoint:
- After signing ICF and until 28 days after the last dose of IP or 28-day Followup Visit, whichever occurs later. Not during survival unless it is a suspected SAE.

1 definida como la incidencia combinada de RC, RP y enfermedad estable (DE) determinada en la visita de final del tratamiento
2 definida como la incidencia combinada de RC y RP
3 definida como el tiempo transcurrido entre la primera dosis del tratamiento del estudio y la progresión de la enfermedad o la muerte
4 definida como el tiempo transcurrido entre la primera dosis del tratamiento del estudio y la muerte
5 durante el tratamiento y después del tratamiento con nab-paclitaxel más gemcitabina en relación con los cuestionarios de calidad de vida QLQ-C30 y QLQ-PAN26 de la EORTC
Seguridad:
Tras firmar el CI y hasta 28 días después de la última dosis o 28 días de la visita de seguimiento, lo que ocurra antes.No durante la supervivencia a menos que sea un AAG sospechado.

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

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.8.2.4

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

Canada

France

Italy

Spain

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date.

El final del ensayo se define como la fecha de la última visita del último sujeto que finalice el
estudio o la fecha de recepción de los últimos datos correspondientes al último sujeto que sean necesarios para los análisis principales, secundarios o exploratorios, tal como se establece en el protocolo o el plan de análisis estadístico (PAE), la que sea posterior.

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

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

F.4.2.2

In the whole clinical trial

110

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)

Patient treatments will be at the discretion of the patient physician

El tratamiento de los pacientes será a discreción del investigador

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

2015-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-26

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