E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic pancreatic cancer |
Cáncer de páncreas metastásico |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic pancreatic cancer |
Cáncer de páncreas metastásico |
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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 | 18.1 |
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) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of implementing an integrated genetics and avatar mouse model personalized treatment strategy to the conventional treatment strategy in patients with metastatic PDAC |
Comparar la eficacia de la implementación de una estrategia con tratamiento convencional personalizado basada en el análisis genético del tumor y el modelo avatar en ratón en pacientes con cáncer de páncreas metastásico |
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E.2.2 | Secondary objectives of the trial |
- To compare the response rates, progression-free survival and CA 19.9 tumor marker modulation effects of patients with metastatic pancreatic cancer treated with a personalized approach to the conventional treatment strategy. - To determine the genomic landscape of metastatic PDAC. - To generate Avatar mouse models from metastatic PDAC. - To develop customized disease monitoring based on mutation analysis in extracellular circulating DNA and circulating exosomes. - To attempt generating Avatar models from circulating tumor cells. |
- Comparar las tasas de respuesta, la supervivencia libre de progresión y los efectos de modulación sobre el marcador tumoral CA 19.9 en pacientes con cáncer de páncreas metastásico tratados con un tratamiento personalizado basado en tratamientos convencionales. - Determinar el mapa genético del cáncer de páncreas metastásico. - Generar modelos de ratón Avatar de cáncer de páncreas metastásico. - Desarrollar una monitorización personalizada de la enfermedad basada en el análisis de mutaciones en el ADN extracelular circulante y exosomas circulantes. - Generar modelos Avatar a partir de células tumorales circulantes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who are 18 years or older; 2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. 3. One or more metastatic tumor sites that are amenable for biopsy. 4. Measurable or evaluable disease. 5. Patients must have received either no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease or be within the first 3 cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed. 6. Adequate blood counts at baseline (obtained <=14 days prior to randomization): - Absolute neutrophil count (ANC) >= 1.5 × 109/L; - Platelet count >= 100,000/mm3 (100 × 109/L); - Hemoglobin (Hgb) >= 9 g/dL. 7. Patient has the following blood chemistry levels at baseline: - AST (SGOT), ALT (SGPT) <= 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then <= 5 × ULN is allowed - Total bilirubin <= 1.5 x ULN - Total albumin >= 0.75 ULN - Serum creatinine <= 1.5 x ULN 8. Eastern Cooperative Oncology Group (ECOG) performance score of 1 or lower. 9. Written informed consent. 10. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception during the study and for 4 months after the last study treatment intake for women and 6 months for men. |
1. Edad mayor de 18 años 2. Confirmación histológica o citológica de adenocarcinoma metastásico de páncreas. 3. Uno o más sitios tumorales metastásicos susceptibles de biopsiar. 4. Enfermedad medible o evaluable. 5. Los pacientes no deben haber recibido radioterapia, cirugía, quimioterapia o cualquier tratamiento en investigación para el tratamiento de la enfermedad metastásica o estará dentro de los 3 primeros ciclos de quimioterapia de primera línea. Se permite la radioterapia paliativa para las metástasis óseas. 6. Hemograma adecuado al inicio del estudio, obtenidos <= 14 días antes de la aleatorización: - Recuento absoluto de neutrófilos (RAN) >= 1,5 x 109 / l; - Plaquetas >= 100.000 / mm3 (100 × 109 / L); - Hemoglobina (Hb) >= 9 g / dl. 7. Bioquímica sanguínea adecuada al inicio del estudio: - AST (SGOT), ALT (SGPT) <= 2.5 × límite superior de normalidad (LSN), a menos que haya presencia de metástasis hepáticas, entonces se permite <= 5 × LSN - Bilirrubina total <= 1,5 x LSN - Albúmina total >= 0,75 LSN - Creatinina sérica <= 1,5 x LSN 8. ECOG PS 0 - 1. 9. Consentimiento informado por escrito. 10. Los pacientes en edad fértil deben estar de acuerdo en utilizar métodos anticonceptivos adecuados durante el estudio. |
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E.4 | Principal exclusion criteria |
1. Known brain metastases, unless previously treated and well-controlled for at least 3 months. 2. Only locally advanced disease. 3. History of malignancy in the last 5 years. 4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 5. Contraindication for performing a tumor biopsy. 6. Known historical or active infection with HIV, hepatitis B, or hepatitis C. 7. High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year. 8. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity. 9. Female patient is pregnant or breast-feeding. 10. Unwilling or unable to comply with study procedures. The patients must be agreeable to performing a tumor biopsy if allocated to the interventional arm. |
1. Metástasis cerebrales conocidas, a menos que hayan sido tratadas previamente y estén controladas durante al menos 3 meses. 2. Únicamente enfermedad localmente avanzada. 3. Historia de cáncer en los últimos 5 años. 4. Infección activa, no controlada, bacteriana, viral o fúngica que requieran tratamiento sistémico. 5. Contraindicaciones para la realización de la biopsia del tumor. 6. Infección previa o activa por VIH, hepatitis B, o hepatitis C. 7. Alto riesgo cardiovascular, incluyendo, pero no limitado a, la implantación reciente de un stent coronario o infarto de miocardio en el pasado año. 8. Factores de riesgo graves que implican cualquiera de los principales órganos, o trastornos psiquiátricos graves, que podrían comprometer la seguridad o la integridad de los datos del estudio. 9. Paciente embarazada o en periodo de lactancia. 10. Pacientes incapaces de cumplir con los procedimientos del estudio. Los pacientes deben estar de acuerdo en la realización de una biopsia del tumor si son asignados al brazo de intervención. |
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E.5 End points |
E.5.1 | Primary end point(s) |
One year survival rate. |
Supervivencia a un año |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Objective tumor response - Progression-free survival - CA 19.9 tumor measurements - Determine whether a correlation exists between mutation analysis in extracellular circulating DNA and efficacy outcomes |
- Tasa de respuesta objetiva - Spervivencia libre de progresión - Variaciones del marcador CA 19.9 - Determinar si existe correlación entre las mutaciones encontradas en el ADN extracelular circulante y las variables de eficacia |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 8-12 weeks |
Cada 8-12 semanas |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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Last visit of the last subject |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |