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临床试验/EUCTR2012-003936-21-BE
EUCTR2012-003936-21-BE进行中（未招募）1 期

A PROSPECTIVE MULTICENTRIC, PROOF OF CONCEPT STUDY TO EVALUATE THE VALUE OF 18-FDG-PET-SCAN ON TUMOUR RESPONSE IN PATIENTS WITH A PROGRESSIVE PANCREATIC ENDOCRINE TUMOUR RECEIVING A COMBINATION THERAPY OF LANREOTIDE AUTOGEL 120 MG EVERY 28 DAYS AND SUNITINIB 37.5 MG DAILY - SULA-P Study

Hôpital de Jolimont0 个研究点开始时间: 2013年9月26日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1) Has provided written informed consent prior to any study-related procedures.
  • •2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide
  • •3) Presenting a positive or negative 18-FDG PET SCAN at study entry
  • •4) Has a World Health Organisation (WHO) performance score lower than or equal to 2.
  • •5) Ki-67 of the tumour is documented and is below 20%.
  • •6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 52
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range
  • •1) Has provided written informed consent prior to any study-related procedures.
  • •2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide
  • •3) Presenting a positive or negative 18-FDG PET SCAN at study entry
  • •4) Has a World Health Organisation (WHO) performance score lower than or equal to 2.
  • •5) Ki-67 of the tumour is documented and is below 20%.
  • •6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 52
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range
  • •1) Has provided written informed consent prior to any study-related procedures.
  • •2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide
  • •3) Presenting a positive or negative 18-FDG PET SCAN at study entry
  • •4) Has a World Health Organisation (WHO) performance score lower than or equal to 2.
  • •5) Ki-67 of the tumour is documented and is below 20%.
  • •6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 52
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1) Has previously been treated with sunitinib
  • •2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion.
  • •3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour.
  • •4) Has been treated with radionuclide at any time prior to study entry
  • •5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib.
  • •6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
  • •7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study.
  • •8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  • •9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
  • •10) Has been previously been enrolled in this study.
  • •1) Has previously been treated with sunitinib
  • •2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion.
  • •3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour.
  • •4) Has been treated with radionuclide at any time prior to study entry
  • •5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib.
  • •6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
  • •7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study.
  • •8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  • •9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
  • •10) Has been previously been enrolled in this study.
  • •1) Has previously been treated with sunitinib
  • •2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion.
  • •3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour.
  • •4) Has been treated with radionuclide at any time prior to study entry
  • •5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib.
  • •6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
  • •7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study.
  • •8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  • •9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
  • •10) Has been previously been enrolled in this study.

研究者

发起方
Hôpital de Jolimont

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