Clinical Trials Register

Summary
EudraCT Number:	2014-003596-27
Sponsor's Protocol Code Number:	BIBABRAX
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

2014-003596-27

A.3

Full title of the trial

A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Estudio fase II de nab-paclitaxel y gemcitabina en pacientes ancianos con adenocarcinoma de páncreas metastático no tratado

A.3.1

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

Study of Nab-paclitaxel and Gemcitabine in Elderly Patients with Pancreatic Cancer

Estudio de nab-paclitaxel y gemcitabina en pacientes ancianos con cáncer de páncreas

A.4.1

Sponsor's protocol code number

BIBABRAX

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	Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Asociación de Oncología Médica del Hospital de Cruces
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	APICES SOLUCIONES, S.L.
B.5.2	Functional name of contact point	Departamento Operaciones Clínicas
B.5.3	Address:
B.5.3.1	Street Address	Salamanca, 7
B.5.3.2	Town/ city	Torrejón de la Calzada (MADRID)
B.5.3.3	Post code	28991
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34918166804103
B.5.5	Fax number	+34918169172
B.5.6	E-mail	juanluis.sanz@apices.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	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	Spain
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 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	nab-paclitaxel
D.3.9.1	CAS number	33069-62-4
D.3.9.3	Other descriptive name	PACLITAXEL ALBUMIN-BOUND
D.3.9.4	EV Substance Code	SUB127678
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	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)	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	Yes
D.2.1.1.1	Trade name	Gemcitabina
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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 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/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	38
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

Metastatic pancreatic cancer

Cáncer de páncreas metastásico

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	17.1
E.1.2	Level	PT
E.1.2	Classification code	10033610
E.1.2	Term	Pancreatic carcinoma metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 efficacy of treatment through 3-months deterioration free rate

Evaluar la eficacia del tratamiento mediante la tasa libre de deterioro a los 3 meses.

E.2.2

Secondary objectives of the trial

- 3 months progression free survival
- Safety profile of this combination using NCI-CTCAE v.4 criteria
- Time to tumor progression
- Overall survival
- Objective radiographic response (ORR)
- CA 19-9 biomarker response

- Supervivencia libre de progresión a los 3 meses
- Perfil de seguridad de la combinación evaluado según los criterios NCI-CTCAE v.4
- Tiempo hasta la progresión
- Supervivencia global
- Tasa de respuesta radiológica objetiva
- Respuesta al marcador tumoral CA 19.9

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically or citologically-confirmed pancreatic adenocarcinoma
2. Stage IV disease (metastatic only)
3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
4. ECOG performance status of 0-1
5. Age >=70 years.
6. Evidence of either or both of the following:
- RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan)
- An elevated serum CA19-9 at baseline ( >= 2X ULN)
7. Female patients must be either surgically sterile or postmenopausal.
8. Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
9. Adequate bone marrow function:
- ANC >= 1500/uL
- platelet count >= 100,000/uL
- hemoglobin >= 9.0 g/dL
10. Adequate hepatic function:
- Total bilirubin <= 1.5 X ULN
- AST (SGOT) <= 2.5 X ULN
- ALT (SGPT) <= 2.5 X ULN
11. Adequate renal function as determined by either:
- Serum creatinine <= 1.5 X ULN
- Calculated or measured creatinine clearance >= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
12. Ability to understand the nature of this study protocol and give written informed consent
13.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

1. Pacientes con diagnóstico de cáncer de páncreas confirmado mediante histología o citología
2. Estadio IV, enfermedad metastásica
3. No haber recibido tratamiento previo para la enfermedad desde el diagnóstico a excepción de quimioterapia adyuvante, al menos 6 meses antes de la entrada del paciente en el estudio
4. ECOG PS 0-1
5. Pacientes >= 70 años
6. Evidencia de al menos uno de los siguientes:
- Enfermedad medible según criterios RECIST (lesiones que pueden medirse con precisión en al menos una dimensión, siendo el diámetro mayor ? 20mm utilizando técnicas convencionales o ?10 mm con TC helicoidal)
- CA19.9 basal elevado ( >= 2 X LSN)
7. Las mujeres deben estar esterilizadas quirúrgicamente o ser postmenopáusicas.
8. Los pacientes varones deben estar esterilizados quirúrgicamente o deben estar de acuerdo en utilizar un preservativo durante las relaciones sexuales con mujeres con posibilidad de quedarse embarazadas mientras estén recibiendo el medicamento del estudio, así como durante los 6 meses siguientes a haber recibido la última dosis.
9. Adecuada función medular:
- Neutrófilos >= 1.500/µL
- Plaquetas >= 100.000/µL
- Hemoglobina >= 9.0 g/dL
10. Adecuada función hepática:
- Bilirrubina total <= 1.5 X LSN
- AST (SGOT) <= 2.5 X LSN
- ALT (SGPT) <= 2.5 X LSN
11. Adecuada función renal determinada mediante:
-Creatinina sérica <= 1.5 X LSN
-Aclaramiento de creatinina medido o calculado >= 40 mL/min. Para calcular el aclaramiento de creatinina se utilizará la fórmula de Cockroft-Gault
12. Capacidad para comprender la naturaleza del estudio y dar su consentimiento informado por escrito
13. Capacidad y posibilidad para completar las vistas del estudio, recibir el tratamiento previsto, realizar las analíticas correspondientes así como el resto de los procedimientos del estudio.

E.4

Principal exclusion criteria

1. Any prior systemic or investigational therapy for metastatic pancreatic cancer.
2. Inability to comply with study and/or follow-up procedures.
3. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
4. Presence of central nervous system or brain metastases.
5. Life expectancy < 12 weeks.
6. Pregnancy (positive pregnancy test) or lactation.
7. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
10. Known, existing uncontrolled coagulopathy.
11. Pre-existing sensory neuropathy > grade 1.
12. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
13. Concurrent/pre-existing use of coumadin.

1. Haber recibido terapia sistémica o algún tratamiento en investigación para el tratamiento del cáncer de páncreas metastásico.
2. Imposibilidad de cumplir con los procedimientos del estudio y del seguimiento.
3. Historia de otra enfermedad, disfunción metabólica, hallazgo exploración física o de anomalía en la analítica que muestre indicios razonables que hagan sospechar de una enfermedad o condición que, en opinión del investigador, haga que el paciente tenga un riesgo alto de tener complicaciones durante el tratamiento o pueda afectar a la interpretación de los resultados del estudio.
4. Presencia de metástasis cerebrales o en el sistema nervioso central.
5. Esperanza de vida <12 semanas.
6. Embarazo (prueba de embarazo positiva) o la lactancia.
7. Enfermedad cancerosa previa, excepto cáncer de piel de células basales tratado adecuadamente, cáncer in situ de cuello uterino, cáncer en estadio I o II tratado adecuadamente del que el paciente se encuentra en remisión completa, o cualquier otro tipo de cáncer del que el paciente ha estado libre de enfermedad durante 5 años.
8. Enfermedad cardiaca clínicamente significativa (por ejemplo, insuficiencia cardíaca congestiva, enfermedad arterial coronaria sintomática y arritmia cardíaca no controlada con medicación) o infarto de miocardio en los últimos 12 meses.
9. Falta de integridad física del tracto gastrointestinal superior o síndrome de malabsorción intestinal.
10. Coagulopatía conocida no controlada.
11. Neuropatía sensorial preexistente > grado 1
12. Cirugía mayor en las 4 semanas previas a la inclusión del paciente en el estudio sin recuperación completa
13. Uso de warfarina a la inclusión en el estudio o concomitante con el tratamiento

E.5 End points

E.5.1

Primary end point(s)

3-months deterioration free rate: % patients free from definitive deterioration. TUDD (Time Until Definitive Deterioration) is defined as the time from randomization to the first observation of a definitive deterioration of the score. A definitive deterioration is considered when the score decreases by more than 10 points as compared to baseline.
EORTC QLQ-C30 will be used to calculate TUDD (Time Until Definitive Deterioration). EORTC QLQ-C30 scores will be calculated every four weeks.

Tasa libre de deterioro a los 3 meses: % de pacientes libres de deterioro. El tiempo hasta el deterioro se define como el tiempo entre la inclusión del paciente en el estudio hasta la primera observación de deterioro definitivo del estado de salud global. Se considera deterioro definitivo cuando la puntuación se reduce en más de 10 puntos respecto al valor basal.
Se utilizará el cuestionario EORTC QLQ-C30 para calcular el tiempo hasta el deterioro definitivo. La puntuación del cuestionario EORTC QLQ-C30 se medirá cada 4 semanas.

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 4 weeks

Cada 4 semanas

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

- 3 months
- every 4 weeks
- every 8 weeks
- every 8 weeks
- every 8 weeks
- every 4 weeks

- 3 meses
- Cada 4 semanas
- Cada 8 semanas
- Cada 8 semanas
- Cada 8 semanas
- Cada 4 semanas

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

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

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

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

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

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

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)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.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)

None

Ninguno

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

2015-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-09

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

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