Clinical Trials Register

Summary
EudraCT Number:	2006-006452-35
Sponsor's Protocol Code Number:	PEP0206
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2007-08-14
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2006-006452-35

A.3

Full title of the trial

A Randomised Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients with Locally Advanced or Metastatic Gastric of Gastroesophageal Junction Adenocarcinoma

“Estudio aleatorizado en fase II de PEP02, irinotecan o docetaxel como tratamiento de segunda línea en pacientes con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado o metastásico ”

A.4.1

Sponsor's protocol code number

PEP0206

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	PharmaEngine Inc.
B.1.3.4	Country	Taiwan
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.3.1	Product name	liposomal irinotecan
D.3.2	Product code	PEP02
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 drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	irinotecan hydrochloride
D.3.9.2	Current sponsor code	PEP02
D.3.9.3	Other descriptive name	liposomal irinotecan hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	5
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	Yes
D.3.11.13.1	Other medicinal product type	standard small molecule
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Campto Irinotecan hydrochloride 100mg/5mL
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer 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.3.4	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 drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Irinotecan hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	20
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	Yes
D.3.11.13.1	Other medicinal product type	standard small molecule
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Taxotere Docetaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma S A
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	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 drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Docetaxel trihydrate
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	40
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	Yes
D.3.11.13.1	Other medicinal product type	standard small molecule

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

Evaluar la respuesta tumoral en adenocarcinoma gástrico o de de la unión gastroesofágica localmente avanzado o metastásico

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10066354
E.1.2	Term	Adenocarcinoma of the gastroesophageal junction

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10063916
E.1.2	Term	Metastatic gastric cancer

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal de este estudio es evaluar la respuesta tumoral objetiva al tratamiento con un sólo fármaco, de PEP02, irinotecan o docetaxel

E.2.2

Secondary objectives of the trial

·evaluar otras variables de eficacia, incluida la supervivencia sin progresión, duración de la respuesta tumoral, tiempo hasta la progresión, tiempo hasta el fracaso terapéutico, índice de control de la enfermedad, índice de supervivencia a 1 año y supervivencia global, del fármaco único PEP02, irinotecan o docetaxel.
·evaluar las toxicidades de los fármacos del estudio.
·investigar la intensidad de la dosis de los fármacos del estudio.
·determinar la farmacocinética de PEP02 e irinotecan.
·investigar la relación de la farmacogenética de PEP02 e irinotecan, incluida la familia UGT1A (UGT1A1 y UGT1A9), con la farmacocinética, toxicidad y eficacia.

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

Estudio aleatorizado en fase II de PEP02, irinotecan o docetaxel como tratamiento de segunda línea en pacientes con adenocarcinoma gástrico o de de la unión gastroesofágica localmente avanzado o metastásico-correlacionado con sub-estudios Pharmacogeneticos

Version del protocolo:1.6 PEP0206 PGx
Periodo del estudio: March 2007-December 2008
Objectivos;
Collect genetic polymorphisms information of UGT-1A family in the metabolic pathway of irinotecan
Correlacionar el polimorfismo genetico de grado 3 y 4 de diarrhoea o neutropenia
Correlacionar el polymorfismo genetico con el tumor responsable del tratamiento estudiado
Correlacionar el polimorfismo genetico con parametros pharmacocineticos - AUC of CPT-11, SN-38, SN-38G and SN-38/SN-38G

E.3

Principal inclusion criteria

(1)Presentar adenocarcinoma gástrico o de de la unión gastroesofágica locamente avanzado (no extirpable) o metastásico, confirmado histológica o citológicamente.
(2)Haber recibido sólo una quimioterapia sistémica previa para la enfermedad localmente avanzada o metastásica, con progresión comprobada de la enfermedad durante la quimioterapia o en los 6 meses siguientes a la finalización de la misma. La quimioterapia administrada con radioterapia simultánea NO se considera como quimioterapia sistémica.
(3)Tener al menos una lesión mesurable según los criterios RECIST.
(4)Tener 18 o más años de edad en el momento de otorgar el consentimiento informado.
(5)Presentar un estado general, según la escala ECOG, de 0, 1 ó 2.
(6)Tener una esperanza de vida > 3 meses.
(7)Poseer una función orgánica y medular adecuada, tal como se define en el protocolo
(8)Presentar ECG normal (sin considerar las arritmias no significativas clínicamente ni los cambios isquémicos)
(9)Tener capacidad para comprender y estar dispuesto a firmar un formulario de consentimiento informado

E.4

Principal exclusion criteria

(1)Haberse sometido a quimioterapia sistémica en las 3 semanas anteriores al comienzo del tratamiento del estudio.
(2)Haberse sometido a radioterapia en las 4 semanas anteriores al comienzo del tratamiento del estudio.
(3)Sufrir metástasis cerebral conocida.
(4)Presentar otros cánceres activos o haberse sometido a tratamiento para otros carcinomas en los cinco últimos años, excepto el de piel (no melanoma) curado y cáncer de cuello uterino tratado in situ.
(5)Haber seguido un tratamiento previo con irinotecan o taxanos (paclitaxel, docetaxel).
(6)Haberse sometido a irradiación previa que afectase a > 30% de la médula ósea activa.
(7)Haberse sometido a cirugía mayor en las 4 semanas previas al comienzo del tratamiento del estudio (la laparotomía o la colocación de una vía no se consideran cirugía mayor).
(8)No haberse recuperado de tratamientos previos.
(9)Presentar una neuropatía periférica preexistente de grado > 2.
(10)Tener antecedentes de reacción alérgica al producto liposomal u otros fármacos formulados con polisorbato.
(11)Sufrir enfermedades concomitantes no controladas que incluyen, entre otras, infección en curso o activa, insuficiencia cardíaca congestiva sintomática, hemorragia gastrointestinal activa, deposiciones líquidas, trastornos del sistema nervioso central o enfermedad psiquiátrica/situación social que limitaría el cumplimiento con los requisitos del estudio o que se considere no elegible para el estudio por el investigador.
(12)Haber recibido cualquier fármaco en investigación o participado en algún estudio con fármacos en investigación en las 4 semanas previas al comienzo del tratamiento del estudio.
(13)Mujeres embarazadas o en período de lactancia (debe realizarse una prueba de embarazo a todas las pacientes en edad fértil antes de entrar en el estudio, y el resultado debe ser negativo).

E.5 End points

E.5.1

Primary end point(s)

-Índice de respuesta tumoral objetivo: se define como la relación entre el número de pacientes con respuesta parcial (RP) o respuesta completa (RC) confirmadas según los criterios RECIST y el número de pacientes aleatorizados.

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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

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

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

30 days after the 6th cycle of chemotherapy

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

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

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

120

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)

Patients will continue to receive the standard treatment of care once the trial has finished

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

2007-10-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-07-30

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials