Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroend… (NCT01648465) | Clinical Trial Compass
TerminatedPhase 2
Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors
Greece25 participantsStarted 2012-08-06
Plain-language summary
The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥ 18 years of age.
✓. Newly diagnosed patients with biopsy-proven well or moderately differentiated advanced (metastatic or unresectable) GI or pancreatic neuroendocrine tumor.
✓. Measurable disease based on RΕCIST 1.1 using a triphase CT scan or multi-phase MRI scan.
✓. Patients with a ki-67 measurement \<20% prior to their enrollment to the study.
✓. Performance status 0-2 on the WHO scale.
✓. Adequate bone marrow function as shown by:ANC ≥ 1.5 x 10\^9/L,Platelets ≥ 100 x 10\^9/L,Hemoglobin \> 9 g/dL.
✓. Adequate liver function as shown by:Serum bilirubin ≤ 1.5 x ULN,ALT/SGPT and AST/SGOT ≤ 2.5 x ULN (ή ≤ 5 x ULN in patients with known liver metastases),INR \< 1.3 (INR \< 3 in patients treated with anticoagulants).
✓. Adequate renal function as shown by: serum creatinine ≤ 1.5 x ULN.
Exclusion criteria
✕. Patients with poorly differentiated or undifferentiated GI or pancreatic neuroendocrine carcinoma.
✕. Previous or concurrent cytotoxic chemotherapy, immunotherapy or radiotherapy.
✕. Hepatic artery embolization or cryoablation of hepatic metastasis within 1 month of study enrollment.
✕. Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus).