A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PHASE III STUDY OF EVEROLIMUS (RAD001) PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN THE TREATMENT OF PATIENTS WITH ADVANCED NET OF GL OR LUNG ORIGIN – RADIANT-4

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2013年6月14日最近更新: 2023年9月4日

研究概览

暂无简介。

•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;

•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;

发起方

OVARTIS BIOSCIENSES PERU S.A.,