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临床试验/EUCTR2012-004550-28-DE
EUCTR2012-004550-28-DE进行中（未招募）1 期

EVINEC: Safety and Tolerability of Everolimus as second-line treatment in poorly differentiated neuroendocrine carcinoma / neuroendocrine carcinoma G3 according to WHO 2010 and neuroendocrine tumor G3 - an investigtor initiated Phase II study. - EVINEC

AIO-Studien-gGmbH0 个研究点开始时间: 2014年10月14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）
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. Signed written informed consent
  • •2. Male or female =18 years of age
  • •3. Patients with poorly differentiated neuroendocrine carcinoma, neuroendocrine carcinoma G3 (NEC – G3 according to WHO 2010) or well or moderately differentiated neuroendocrine carcinoma (NET – G1/ G2) that switched to G3 (confirmed by histology) or neuroendocrine tumor G3 (NET G3) and disease progression as measured by RECIST 1.1
  • •4. Progression during or after treatment with first-line platin-based chemotherapy. In NET G3 that switched from NET G2 the line of therapy is determined from time of revised histology (confirming a G3 NEN)
  • •5. Measurable disease according to RECIST 1.1
  • •6. ECOG status 0-2 (Karnofsky Performance status =80%)
  • •7. Women of child-bearing potential must have a negative pregnancy test
  • •8. Laboratory requirements:
  • •Hematology
  • •o Absolute neutrophil count =1.5x10^9/L
  • •o Platelet count =100x10^9/L
  • •o Leukocyte count =3.0x10^9/L
  • •o Hemoglobin =9 g/dL or 5.59 mmol/l
  • •Hepatic Function
  • •o Total bilirubin =1.5 time the upper limit normal (ULN)
  • •o AST =3xULN in absence of liver metastases, or =5xULN in presence of liver metastases
  • •o ALT =3xULN in absence of liver metastases, or =5xULN in presence of liver metastases
  • •Renal Function
  • •o Creatinine clearance =50 mL/min according to Cockroft-Gault formula
  • •Metabolic Function
  • •o Magnesium = lower limit of normal
  • •o Calcium = lower limit of normal
  • •o CRP (PCT if CRP is elevated to exclude infection)
  • •o negative urinary screening test for leucocytes and nitrite to exclude urinary tract infection (U - stix)
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their exipients.
  • •2. Previous therapy with mTOR inhibitor
  • •3.Radiotherapy :
  • •Concurrent radiotherapy involving target lesions used for this study.
  • •Concurrent palliative radiation (but radiation for non-target lesions is allowed if other target lesions are available outside the involved field)
  • •previous pre-operative or post-operative radiotherapy within 3 months before study treatment
  • •4. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
  • •5. Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
  • •6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =1year before enrolment
  • •7. Inadequate pulmonary function according to the Investigator’s judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • •8. Known active HBV, HCV or HIV infection
  • •9. Serious concomitant disease or medical condition that in the judgment of the investigator renders the patient at high risk from treatment complication
  • •10. Any systemic disease requiring oral intake of corticosteroids (except for replacement therapy of corticosteroids – hydrocortisone in case of adrenal or pituitary insufficiency)
  • •11. Hearing loss = Grade 3 (CTCAE v4.03) 12. Patient pregnant or breast feeding, or planning to become pregnant within 8 weeks after the end of treatment
  • •13. Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 8 weeks (male or female) after the end of treatment.
  • •14. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 28 days prior to treatment start
  • •15. Concurrent treatment with inhibitors (e.g. itraconazol, ketoconazol) and inducers (e.g. phenytoin, rifampicin) of CYP3A4 and/or the multidrug efflux pump P-glycoprotein (PgP).
  • •16. Known drug abuse/alcohol abuse
  • •17.Peripheral polyneuropathy = Grade 2 (CTCAE v4.03)
  • •18. Active chronic inflammatory bowel disease
  • •19. Any condition which might interfere with study objectives (e.g. infections) or would limit the patient’s ability to complete the study in the opinion of the investigator
  • •20. Patient who has be incarcerated or involuntarily institutionalized by court order or the authorities (AMG § 40, Abs. 1 No. 4).
  • •21. Affected persons who might be dependent on the sponsor or the investigator

研究者

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