Clinical Trials Register

Summary
EudraCT Number:	2014-001408-23
Sponsor's Protocol Code Number:	ABI-007-PANC-007
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-11-25
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

Italy - Italian Medicines Agency

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®) somministrato in associazione a gemcitabina in soggetti con tumore del pancreas localmente avanzato (LAPC): studio di fase 2, internazionale, in aperto, multicentrico (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

Studio di Abraxane e Gemcitabina per il trattamento di pazienti con tumore al pancreas che non possono subire un intervento chirurgico a causa della posizione del tumore.

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	+1888-260-1599
B.5.5	Fax number	+1913-266-0394
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	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.3.4	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	The IMP contains an excipient of biological origin, albumin, a non-active stabilising agent. It is derived from human blood subject to approved donor screening and product manufacturing processes.
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

Tumore al pancreas localmente avanzato

E.1.1.1

Medical condition in easily understood language

Locally Advanced Pancreatic Cancer

Tumore al pancreas localmente avanzato

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

Valutare il tempo al fallimento del trattamento in pazienti con LAPC trattati con nab-paclitaxel più gemcitabina come terapia di induzione seguita dal trattamento scelto dallo Sperimentatore

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)

Valutare il tasso di controllo della malattia (DCR) dopo i primi 6 cicli di nab-paclitaxel più gemcitabina
•- Valutare il tasso di risposta globale (ORR)
•-Valutare la sopravvivenza libera da progressione (PFS) globale e la sopravvivenza globale (OS)
•-Valutare il profilo di sicurezza globale
•-Valutare la qualità di vita (QoL) correlata alla salute del soggetto

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

•Pazienti oncologici con adenocarcinoma pancreatico non metastatico, non resecabile
•Nessuna precedente terapia antitumorale per il cancro del pancreas
•Età ≥ 18 anni con un performance status di 0 o 1
•Conte ematiche complete, funzione epatica e funzione renale adeguate
•Consenso informato firmato

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

•Infezione attiva di origine batterica, virale o fungina
•Infezione con epatite B o C, o anamnesi di infezione da virus dell’immunodeficienza umana (HIV) o attuale trattamento con immunosoppressori o mielosoppressori
•Soggetti con neuropatia sensoriale, ascite o stent biliare in plastica.
•Gravi fattori di rischio medico che interessano uno qualsiasi dei sistemi organici principali o disturbi psichiatrici gravi (inclusi, in via non limitativa, disturbi del tessuto connettivo, malattia polmonare, disturbi cardiaci o epilettici)
•Donne in gravidanza o allattamento

E.5 End points

E.5.1

Primary end point(s)

Time to treatment failure

Tempo al fallimento del trattamento

E.5.1.1

Timepoint(s) of evaluation of this end point

Time after the first dose of study therapy to treatment failure

Tempo al fallimento del trattamento dopo la prima dose della terapia dello studio

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. DCR dopo 6 cicli di nab-paclitaxel più gemcitabina
2. ORR
3. PFS
4. OS
5. differenze negli esiti rispetto al basale

Endpoint di sicurezza secondario:
- incidenza di AE, SAE, anomalie nei risultati di laboratorio e altri parametri di sicurezza derivanti dal trattamento

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.

•Endpoint di efficacia secondari:
•definiti come l’incidenza combinata di risposta completa, risposta parziale e malattia stabile misurati in sede di visita di fine trattamento
•definiti come l’incidenza combinata di CR e PR
•definiti come il tempo alla progressione della malattia o al decesso (per qualsiasi causa) dopo la prima dose della terapia dello studio
•definiti come il tempo al decesso (per qualsiasi causa) dopo la prima dose della terapia dello studio
•durante e dopo il trattamento con nab-paclitaxel più gemcitabina per i questionari EORTC sulla qualità di vita, EORTC QLQC30 e QLQ-PAN26
Endpoint di sicurezza secondario:
•Dopo aver firmato l’ICF e fino a 28 giorni dopo l’ultima dose dell’IP o alla visita di follow-up a 28 giorni, a seconda di quale evento si verifichi .....

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

Yes

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)

Yes

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.

La fine della sperimentazione è definita come la data dell’ultima visita dell’ultimo soggetto che completa lo studio o la data di ricezione dell’ultimo dato raccolto relativo all’ultimo soggetto, necessario per l’analisi primaria, secondaria e/o esplorativa, come prestabilito nel protocollo e/o nel piano di analisi statistica, a seconda di quale sia la data più tardiva.

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

I trattamenti del paziente saranno a discrezione del medico del paziente

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

2015-01-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-05

P. End of Trial
P.	End of Trial Status	Completed

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