Clinical Trials Register

Summary
EudraCT Number:	2012-002400-40
Sponsor's Protocol Code Number:	CTTG01-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-07-31
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

2012-002400-40

A.3

Full title of the trial

A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas

Ensayo de fase I/II de TG01 y gemcitabina como tratamiento adyuvante para tratar a pacientes con adenocarcinoma resecado del páncreas

A.3.1

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

A Phase I/II Trial of TG01 and Gemcitabine as adjuvant therapy for treating patients with pancreatic cancer

Ensayo de fase I/II de TG01 y gemcitabina como tratamiento adyuvante para tratar a pacientes con cáncer de páncreas

A.3.2

Name or abbreviated title of the trial where available

Not applicable

A.4.1

Sponsor's protocol code number

CTTG01-01

A.5.4

Other Identifiers

Name:

not applicable

Number:

Not applicable

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	Targovax AS
B.1.3.4	Country	Norway
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	Targovax AS
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	León Research S.L.
B.5.2	Functional name of contact point	Rocío García Cañamaque
B.5.3	Address:
B.5.3.1	Street Address	Burgo Nuevo 16, 1-G
B.5.3.2	Town/ city	León
B.5.3.3	Post code	24001
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34987261064
B.5.5	Fax number	+34987216243
B.5.6	E-mail	rgcanamaque@leonresearch.es

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	Yes
D.2.5.1	Orphan drug designation number	EU/3/11/885
D.3 Description of the IMP
D.3.2	Product code	TG01
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.2	Current sponsor code	12A
D.3.9.3	Other descriptive name	12-A- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-02-4
D.3.9.2	Current sponsor code	12C
D.3.9.3	Other descriptive name	12-C- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-03-5
D.3.9.2	Current sponsor code	12D
D.3.9.3	Other descriptive name	12-D- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-04-6
D.3.9.2	Current sponsor code	12R
D.3.9.3	Other descriptive name	12-R- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-05-7
D.3.9.2	Current sponsor code	12S
D.3.9.3	Other descriptive name	12-S- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-06-8
D.3.9.2	Current sponsor code	12V
D.3.9.3	Other descriptive name	12-V- p21 RAS(5-21)
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	0.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	242452-07-9
D.3.9.2	Current sponsor code	13D
D.3.9.3	Other descriptive name	13-D- p21 RAS(5-21)
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	0.1
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.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	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	GM-CSF
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MOLGRAMOSTIM
D.3.9.1	CAS number	99283-10-0
D.3.9.4	EV Substance Code	SUB09040MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	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	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.IMP: 3
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	GEMZAR 200 mg powder for solution for infusion. GEMZAR 1000 mg powder for solution for infusion.
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly and Company 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.3.1	Product name	Gemcitabine
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	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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.IMP: 4
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.2.5	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	Fluorouracil
D.3.4	Pharmaceutical form	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	FLUOROURACIL
D.3.9.1	CAS number	51-21-8
D.3.9.3	Other descriptive name	5-FU
D.3.9.4	EV Substance Code	SUB02225MIG
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	50
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.IMP: 5
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.2.1.2	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.3.1	Product name	Folinic acid
D.3.4	Pharmaceutical form	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	Folinic acid
D.3.9.3	Other descriptive name	leucovorin
D.3.9.4	EV Substance Code	SUB06052MIG
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)	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

Adenocarcinoma of the Pancreas

Adenocarcinoma de Pancreas

E.1.1.1

Medical condition in easily understood language

Pancreatic cancer

Cáncer de Páncreas

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10033604
E.1.2	Term	Pancreatic cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. To assess the safety of GM-CSF/TG01 vaccination and adjuvant chemotherapy
2. To assess the immune response to GM-CSF/TG01 and the effect of adjuvant chemotherapy in patients receiving GM-CSF/TG01 after primary resection of pancreatic adenocarcinoma

1.Evaluar la seguridad de la vacunación con GM-CSF/TG01 y la quimioterapia adyuvante
2.Evaluar la respuesta inmunitaria a GM-CSF/TG01 y el efecto de la quimioterapia adyuvante en pacientes que reciben GM-CSF/TG01 después de la resección primaria del adenocarcinoma pancreático

E.2.2

Secondary objectives of the trial

3. To assess at 2 years the clinical efficacy of GM-CSF/TG01 in patients with resected pancreatic cancer

3. Evaluar a los 2 años la eficacia clínica de GM-CSF/TG01 en pacientes con cáncer pancreático resecado

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
2. Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
3. Successful surgical resection
-Complete resection (R0) or with microscopic residual disease (R1)
-Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
4. Laboratory Values:
-Absolute neutrophil count more than or equal to 1.5 x 10exp9/l
-Platelets more than or equal to 100 x 10exp9/l
-Haemoglobin more than or equal to 9 g/dl
-Total bilirubin less than or equal to 1.5 x UNL
-Serum creatinine less than or equal to 1.5 x UNL
-Albumin more than or equal to 2.5 g/dl
-AST or ALT less than or equal to 5 x UNL
5. 18 years of age or older.
6. ECOG performance status (PS) of 0-1.
7. Life expectancy of at least 6 months
8. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
9. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures

1. Diagnóstico de adenocarcinoma del páncreas confirmado histológicamente o citológicamente.
2. Enfermedad en estadio I o II (estadio clínico T1-3, N0-1, M0 según los criterios de clasificación por estadios AJCC).
3. Resección quirúrgica con éxito.
- Resección completa (R0) o con enfermedad residual microscópica (R1).
- Está previsto que reciba gemcitabina en monoterapia como quimioterapia adyuvante.
4. Valores de laboratorio:
- Recuento absoluto de neutrófilos más que igual a 1,5 x 10exp9/l
- Plaquetas más que igual a 100 x 10exp9/l
- Hemoglobina más que igual a 9 g/dl
- Bilirrubina total menos que igual a 1,5 veces el LSN
- Creatinina sérica menos que igual a 1,5 veces el LSN
- Albúmina más que igual a 2,5 g/dl
- AST o ALT menos que igual a 5 veces el LSN
5. 18 años de edad o más.
6. Estado funcional ECOG (PS) de 0-1.
7. Esperanza de vida de al menos 6 meses.
8. Los varones y las mujeres en edad fértil deben estar dispuestos a usar métodos anticonceptivos eficaces para evitar el embarazo.
9. Proporcionar el consentimiento informado (firmado) por escrito para participar en el ensayo antes de realizar cualquier procedimiento de selección específico del ensayo.

E.4

Principal exclusion criteria

1. Has received an investigational drug within 4 weeks prior to Trial drug administration
2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy)
3. Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma)
4. Has any other serious illnesses or medical conditions such as, but not limited to:
-Any uncontrolled infection
-Uncontrolled cardiac failure classification III or IV (NY Heart Association)
-Uncontrolled systemic and gastro-intestinal inflammatory conditions
-Bone marrow dysplasia
-History of auto-immune disease
-History of adverse reactions to vaccines
5. Known history of positive tests for HIV/AIDS, hepatitis B or C
6. Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
7. Contraindication to Gemcitabine treatment
8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
9. Known malignant brain lesion(s)
10. Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
11. Are not expected to complete 6 cycles of chemotherapy
12. Are planned to receive yellow fever or live (attenuated) vaccines during the course of study (see prohibited medications).

1. Ha recibido un fármaco en investigación en las 4 semanas anteriores a la administración del fármaco del ensayo.
2. Ha recibido tratamiento anterior para el cáncer de páncreas, incluida la radiación o quimioterapia (exceptuando la resección primaria o la quimioterapia neoadyuvante primaria).
3. Está recibiendo actualmente algún producto que se sabe que tiene efectos en el sistema inmunitario, a menos que sea a niveles de dosis no inmunosupresores (p. ej.: prednisona a 10 mg/día o menos o como esteroide inhalado en dosis utilizadas para tratar el asma).
4. Tiene alguna otra enfermedad o afección médica grave, como por ejemplo, entre otras:
- Alguna infección no controlada
- Insuficiencia cardíaca no controlada de clasificación III o IV (NY Heart Association)
- Enfermedades inflamatorias gastrointestinales y sistémicas no controladas Enfermedades inflamatorias
- Displasia de médula ósea
- Antecedentes de enfermedad autoinmunitaria.
- Antecedentes de reacciones adversas a vacunas.
5. Antecedentes conocidos de pruebas positivas de VIH/SIDA, hepatitis B o C.
6. Mujeres embarazadas o en período de lactancia o que no se han sometido a una prueba de embarazo al inicio (las mujeres postmenopáusicas deben llevar siendo amenorreicas al menos 12 meses para que se considere que no están en edad fértil).
7. Contraindicación al tratamiento con gemcitabina.
8. Haber tenido otras neoplasias malignas en los 3 últimos años (excepto en caso de carcinoma del cuello uterino o carcinoma basocelular o de células escamosas de la piel adecuadamente tratados).
9. Lesión o lesiones cerebrales malignas conocidas.
10. Improbabilidad de iniciar la quimioterapia en un plazo de 12 semanas desde la cirugía (p. ej.: curación tardía de las heridas, o infección, etc.).
11. No se prevé que complete 6 ciclos de quimioterapia.
12. Está previsto que reciba vacunas para la fiebre amarilla u otras vivas (atenuadas) durante el transcurso del estudio (consulte la sección de medicación concomitante).

E.5 End points

E.5.1

Primary end point(s)

Primary:
Efficacy - Immune response (DTH responses and proliferative T-cell responses)

Safety - Adverse events and laboratory assessments

Primarios
Eficacia - Respuesta inmunitaria (Respuestas de DTH y Respuestas de los linfocitos T proliferativos)

Seguridad - Acontecimientos adversos y Evaluaciones de laboratorio

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety: Assessed during the study until the end of the study. No specific timepoint.

Immune Response: by week 11 or 12 (main group), week 13 (concomitant group), or by week 8 (modified vaccination group) at end of the treatment period with chemotherapy and at end of study.

Seguridad: Evaluaciones durante el estudio y hasta el final del mismo. No hay momentos específicos.

Respuesta inmunitaria: en la semana 11-12 (grupo principal), 13 (grupo concomitante), o por semana 8 (grupo de vacunación modificado) al finalizar el tratamiento con quimioterapia y al finalizar el estudio.

E.5.2

Secondary end point(s)

Secondary:
-Efficacy (DFS and overall survival)

Exploratory:
-Relationship between KRAS status in resected primary tumour and recurrence survival outcomes
-CA19-9 levels

Secundarios:
Eficacia (DFS y supervivencia total)

Exploratorios:
- Relación entre el estado de KRAS en el tumor primario resecado y los resultados de supervivencia con recurrencias
- Monitorización de los niveles de CA19-9

E.5.2.1

Timepoint(s) of evaluation of this end point

Assessed during the study until the end of the study. Up to 2 years. Samples will be collected at given timepoints as specified in the protocol.

Evaluaciones durante el estudio y hasta el final del mismo. Hasta 2 años. Las muestras se recogen en los puntos de tiempo indicados como se especifica en el protocolo.

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

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

The relationship of KRAS status to recurrence

Relación entre el estado KRAS y la recurrencia

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Potential for interference between Gemcitabine and TG01/GM-CSF treatments

Potenciales interacciones entre los tratamientos con Gemcitabine y TG01/GM-CSF

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

Ultima visita del último paciente

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

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

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)

Standard of care

Práctica clínica habitual

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-09-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-23

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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