None listed
Conditions
Interventions
AFTER ASSESSMENT OF ELIGIBILITY, PATIENTS QUALIFYING FOR THE STUDY WILL BE RANDOMIZED IN A 2:1 RATIO, WITH TWO PATIENTS BEING RANDOMLY ASSIGNED TO EVEROLIMUS TREATMENT FOR EVERY ONE PATIENT RANDOMLY A
THE SSA PRETREATED STRATUM IS DEFINED AS PATIENTS WHO HAD CONTINUOUSLY RECEIVED SSA FOR ≥
12 WEEKS ANY TIME PRIOR TO STUDY INCLUSION),
2. TUMOR ORIGIN (A. APPENDIX, CAECUM, JEJUNUM, ILEUM, DUODENUM, AND CUP
VS. B. LUNG, STOMACH, LIVER, RECTUM, AND COLON EXCEPT CAECUM),
3. WHO PERFORMANCE STATUS (0 VS. 1).
THIS STUDY WILL ENROLL APPROXIMATELY 279 PATIENTS GLOBALLY. PATIENTS WILL RECEIVE DAILY ORAL D
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. PATHOLOGICALLY CONFIRMED, WELL-DIFFERENTIATED (G1 OR G2), ADVANCED (UNRESECTABLE OR METASTATIC), NEUROENDOCRINE TUMOR OF GI OR LUNG ORIGIN; 2. NO HISTORY OF AND NO ACTIVE SYMPTOMS RELATED TO CARCINOID SYNDROME; 3. IN ADDITION TO TREATMENT-NAÏVE PATIENTS, PATIENTS PREVIOUSLY TREATED WITH SSA, INTERFERON (IFN), ONE PRIOR LINE OF CHEMOTHERAPY, AND/OR PRRT ARE ALLOWED INTO THE STUDY. PRETREATED PATIENTS MUST HAVE PROGRESSED ON OR AFTER THE LAST TREATMENT. 4. PATIENTS MUST HAVE DISCONTINUED TREATMENT PRIOR TO THE DAY OF RANDOMIZATION AS FOLLOWS: A. PRIOR SSA FOR AT LEAST 4 WEEKS B. PRIOR IFN FOR AT LEAST 4 WEEKS; C. PRIOR CHEMOTHERAPY FOR AT LEAST 4 WEEKS; D. PRIOR PRRT FOR AT LEAST 6 MONTHS 5. RADIOLOGICAL DOCUMENTATION OF DISEASE PROGRESSION WITHIN 3 MONTHS PRIOR TO RANDOMIZATION (I.E. 12 WEEKS FROM DOCUMENTATION OF PROGRESSION UNTIL RANDOMIZATION); 6. MEASURABLE DISEASE ACCORDING TO RECIST 1.0 (APPENDIX 1) DETERMINED BY MULTIPHASIC COMPUTER TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). ANY LESIONS WHICH HAVE BEEN SUBJECTED TO PERCUTANEOUS THERAPIES, SURGERY, OR RADIOTHERAPY SHOULD NOT BE CONSIDERED MEASURABLE, UNLESS THE LESION HAS CLEARLY PROGRESSED SINCE THE PROCEDURE;
Exclusion criteria
Exclusion criteria: 1. PATIENTS WITH POORLY DIFFERENTIATED NEUROENDOCRINE CARCINOMA, HIGH-GRADE NEUROENDOCRINE CARCINOMA, ADENOCARCINOID, PANCREATIC ISLET CELL CARCINOMA, INSULINOMA, GLUCAGONOMA, GASTRINOMA, GOBLET CELL CARCINOID, LARGE CELL NEUROENDOCRINE CARCINOMA AND SMALL CELL CARCINOMA; 2. PATIENTS WITH NET ORIGINS OTHER THAN GI AND LUNG; 3. PATIENTS WITH HISTORY OF OR ACTIVE SYMPTOMS OF CARCINOID SYNDROME; 4. MORE THAN ONE PRIOR LINE OF CHEMOTHERAPY 5. PRIOR TARGETED THERAPY 6. HEPATIC INTRA-ARTERIAL EMBOLIZATION WITHIN THE LAST 6 MONTHS. CRYOABLATION OR RADIOFREQUENCY ABLATION OF HEPATIC METASTASES WITHIN 2 MONTHS OF RANDOMIZATION; 7. PRIOR THERAPY WITH MTOR INHIBITORS (E.G. SIROLIMUS, TEMSIROLIMUS, DEFOROLIMUS); 8. KNOWN INTOLERANCE OR HYPERSENSITIVITY TO EVEROLIMUS OR OTHER RAPAMYCIN ANALOGS (E.G. SIROLIMUS, TEMSIROLIMUS); 9. KNOWN IMPAIRMENT OF GASTROINTESTINAL (GI) FUNCTION OR GI DISEASE THAT MAY SIGNIFICANTLY ALTER THE ABSORPTION OF ORAL EVEROLIMUS; 10. UNCONTROLLED DIABETES MELLITUS AS DEFINED BY HBALC >8% DESPITE ADEQUATE THERAPY. PATIENTS WITH A KNOWN HISTORY OF IMPAIRED FASTING GLUCOSE OR DIABETES MELLITUS (DM) MAY BE INCLUDED, HOWEVER BLOOD GLUCOSE AND ANTIDIABETIC TREATMENT MUST BE MONITORED CLOSELY THROUGHOUT THE TRIAL AND ADJUSTED AS NECESSARY;
Countries
Arabia Saudi, Austria, Belgium, Canada, China, Colombia, Czech Republic, Germany, Greece, Hungary, Italy, Japan, Korea North, Lebano, Netherlands, Norway, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States
Outcome results
None listed