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Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) (RegARd-C)

21 de junio de 2019 actualizado por: Jules Bordet Institute

Regorafenib Assessment in Refractory Advanced Colorectal Cancer

The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory.

Secondary objectives:

  • To analyze PFS and response rate (RR) in relationship with the same covariates as for OS
  • To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study population.
  • To assess the Disease control rate (DCR = Complete response [CR] + partial response [PR] + stable disease [SD])
  • To compare the relative benefit (OS, PFS) of regorafenib according to history of treatment with bevacizumab.

Tipo de estudio

Intervencionista

Inscripción (Actual)

141

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Bélgica
      • Brussels, Bélgica, 1000
        • Jules Bordet Institute
      • Brussels, Bélgica, 1070
        • Hôpital Erasme
      • Brussels, Bélgica
        • Cliniques Universitaires Saint Luc
      • Charleroi, Bélgica, 6000
        • Grand Hôpital de Charleroi
      • Ghent, Bélgica
        • UZ Ghent
      • Kortrijk, Bélgica, 8500
        • AZ Groeninge
      • Liège, Bélgica, 4000
        • Centre Hospitalier Universitaire de Liege
      • Liège, Bélgica, 4000
        • Clinique St Joseph
      • Lobbes, Bélgica, 6540
        • Centre Hospitalier de Jolimont
      • Mons, Bélgica, 7000
        • CHU Ambroise Pare
      • Namur, Bélgica, 5000
        • Centre Hospitalier Regional De Namur
      • Namur, Bélgica, 5000
        • Clinique et Maternite Sainte Elisabeth
      • Ottignies, Bélgica, 1340
        • Clinique Saint Pierre
      • Roeselare, Bélgica, 8800
        • Hartziekenhuis Roeselare-Menen (HHRM)
      • Turnhout, Bélgica, 2300
        • AZ Turnhout
      • Yvoir, Bélgica, 5530
        • Cliniques Universitaires UCL de Mont-Godinne
    • Edegem
      • Antwerpen, Edegem, Bélgica, 2650
        • UZA

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Histologically proven colorectal adenocarcinoma that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
  2. Age ≥ 18 years.
  3. Life expectancy of greater than 12 weeks.
  4. ECOG performance status ≤ 1.

  5. Participants must have normal organ and bone marrow function as defined below:

    • Leukocytes >3,000/mcL,with an absolute neutrophil count >1,500/mcL, platelets >100,000/mcL, Hb >or=9g/dl.
    • Total bilirubin≤1.5×institutional ULN.
    • AST/ALT/P-Alk levels ≤ 2.5 × institutional ULN (≤5x institutional ULN in case of liver metastatic involvement).
    • Lipase ≤1.5 institutional ULN.
    • coagulation tests ≤ 1.5 x institutional ULN.
    • Creatinine ≤ 1.5× institutional ULN or creatinine clearance >30mL/min according to the Modified Diet in Renal Disease (MDRD) abbreviated formula.
  6. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, until at least 3 months after the last study drug administration.
  7. Signed Written Informed Consent (IC).
  8. Presence of a previously collected or freshly obtained at the time of study entry frozen metastatic tumor biopsy in a FDG-PET targetable lesion.
  9. Presence of at least one metabolically measurable tumoral lesion on FDG PET-CT

Exclusion Criteria:

  1. Prior treatment with sorafenib or regorafenib
  2. Patients with previous cancer that is not disease-free for at least for 5 years prior to registration, EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
  3. Participants who have had a major surgery, chemotherapy or radiotherapy within 4 weeks prior to entering the study.
  4. Unresolved toxicity higher than NCI-CTCAE (version 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ≤Grade 2.
  5. Participants receiving any experimental agents.
  6. Participants with known brain metastases.
  7. Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
  8. Any hemorrhage or bleeding event NCI-CTCAE v.4 Grade >or= 3 within 4 weeks prior to the start of study medication.
  9. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure (New York Heart Association (NYHA)class> or=2), unstable angina pectoris, cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  10. Uncontrolled hypertension.
  11. Patients with seizure disorder requiring medication.
  12. Any history of organ allograft.
  13. Pleural effusion or ascites affecting respiration.
  14. Uncontrolled diabetes.
  15. Non-healing wound, ulcer, or bone fracture.
  16. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
  17. Interstitial lung disease with ongoing signs and symptoms.
  18. Renal failure requiring hemo-or peritoneal dialysis.
  19. Dehydration NCI-CTCAE v.4 grade >1.
  20. Medical,psychological or social conditions that may interfere with the patient's ability to understand informed consent and participation in the study or evaluation of the study results.
  21. Known hypersensitivity to the study drug or excipients in the formulation.
  22. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
  23. Pregnant or lactating women.
  24. Subjects unable to swallow oral medications.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Regorafenib
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Droga: regorafenib
Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Otros nombres:
  • stivarga (registred name)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: 2 years from first patient in
2 years from first patient in

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Occurence of Adverse events
Periodo de tiempo: Every 28 days till 28 days after stopping therapy. An average of 2 months is expected.
Assessment of safety will follow the WHO guidelines and classified according to NCI-CTCAE v. 4.0 and will be performed every 28 days until 28 days (safety follow up visit) after stopping therapy. Reasons for stopping therapy may include progression of disease or unbearable toxicities, or patient's decision.
Every 28 days till 28 days after stopping therapy. An average of 2 months is expected.
Evaluation of tumour response
Periodo de tiempo: Every 2 months till progression of the disease. An average of 2 months is expected.
RECIST 1.1-based radiological assessment (CT or MRI) will be made every 2 cycles, starting at day 28 of the second cycle till demonstration of progressive disease. An average of 2 months is expected.
Every 2 months till progression of the disease. An average of 2 months is expected.
Metabolic response assessed by FDG PET
Periodo de tiempo: 2 FDGPET will be perfomed : at Baseline (day 0) and at D14
FDGPET will be done twice during the study course : at baseline (at day 0, before treatment begin) and after 2 weeks.
2 FDGPET will be perfomed : at Baseline (day 0) and at D14
Molecular aberrations
Periodo de tiempo: at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected.
Genetic, epigenetic and molecular aberrations will be investigated using gene expression profiling, RNA and exome sequencing, and methylation profiling on the tumor biopsies and repeated blood samples collected during the trial. The relationship between the molecular aberrations,the patient's outcome (PFS, OS) and with metabolic response after treatment with regorafenib will be studied.
at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Jules Bordet Institute

Investigadores

  • Silla de estudio: Alain Hendlisz, MD, Jules Bordet Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2013

Finalización primaria (Actual)

13 de mayo de 2016

Finalización del estudio (Actual)

17 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2013

Primero enviado que cumplió con los criterios de control de calidad

21 de agosto de 2013

Publicado por primera vez (Estimar)

28 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

21 de junio de 2019

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2012-005655-16 EUDRACT

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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