A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). - COMPETE

ITM Solucin GmbH0 个研究点目标入组 300 人开始时间: 2017年4月20日最近更新: 2024年4月29日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ITM Solucin GmbH
入组人数: 300

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

•All patients must meet all of the following criteria:
•1. Written informed consent
•2. Male or female = 18 years of age
•3. Histologically confirmed diagnosis of well-differentiated neuroendocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET), tumour grade G1 or G2 (Ki-67 < 20%), unresectable or metastatic in a patient who is either treatment-naïve (1st line) or who has progressed under prior therapy (2nd line)
•4. Availability of existing biopsy specimen from primary tumour or metastasis or, if unavailable, willingness to undergo current biopsy for secondary central analysis
•5. Measurable disease per RECIST 1.1, on CT/MRI scans, defined as at least 1 lesion with = 1 cm in longest diameter, and = 2 radiological tumour lesions in total. A maximum of 5 target lesions visible on CT/MRI will be defined, thereof not more than 2 lesions per organ
•6. Somatostatin receptor positive (SSTR+) disease, as evidenced by SSTR imaging (SRI) within 4 months prior to randomisation, as locally authorised, by:
•68Ga-based SSTR positron emission tomography (PET) imaging ( 68Ga-edotreotide or 68Ga-DOTATATE), or
•111In-pentetreotide SSTR SPECT/planar imaging, or
•99mTc-octreotide SSTR SPECT/planar imaging
•64Cu-based SSTR PET imaging (64Cu-DOTATATE), if approved, according to local regulations
•All target lesions and = 90% of non-target lesions need to be positive for SSTR; this relates to lesions of at least 15 mm in diameter acquired on SRI images with SPECT, and of at least 10 mm in diameter acquired on SRI images with PET systems.
•7. The patient must have progressive disease based on RECIST 1.1
•Criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI), within a maximum of 36 months prior to randomisation. The most recent scan must not be older than 90 days prior to randomisation date. The minimum interval
•between the two scans must be = 90 days.
•8. Karnofsky performance status (KPS) scale = 70
•9. Life expectancy allows the patient to participate in the study based on the investigator’s assessment
•10. Glomerular filtration rate (GFR, CKD-EPI) = 60 mL/min/1.73 m^2
•11. For patients included in France only, verification and confirmation of their affiliation with a social security
•12. Patients with functional P-NETs who require SSA for symptom
•control may continue SSA treatment throughout the study, on condition
•a) they have been on a stable dose for at least three months prior to study enrolment
•b) that progressive disease has been diagnosed while under such stable dose
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

排除标准

•A patient will be excluded from participation in the trial if one or more of
•the following criteria are met:
•1. Known hypersensitivity to edotreotide or everolimus
•2. Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
•3. Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution
•4. Prior exposure to any peptide receptor radionuclide therapy (PRRT), including 177Lu-edotreotide, 90Y-edotreotide or other SSTR-targeting agents (e.g. 177Lu-octreotate or high-dose 111In-pentetreotide)
•5. Prior therapy with mTOR inhibitors
•6. Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomization or radioembolisation therapy (e.g. 90Y microspheres, 131I-lipiodol) with administration to the liver
•7. Prior therapy with chemotherapy, immunotherapy, interferon, chemo-embolisation, bland embolisation, cyclosporine-A within 4 weeks before randomisation; any new cancer treatment between screening and randomisation
•8. Therapy with an investigational compound and/or medical device within 30 days or 5 half-life periods (whichever is longer) prior to randomisation
•9. Subjects who have received a live vaccine up to 4 weeks prior to first dose
•10. Current therapy with any prohibited medication (see 6.1.1)
•11. Ongoing toxicity grade 2 according to CTCAE version 4.03 from previous standard or investigational therapies
•12. Indication for surgical lesion removal with curative potential
•13. Planned (for the period of study participation): chemotherapy, immunotherapy, interferon, radiation therapy, chemo-embolisation, bland embolisation, radio-embolisation, treatment with cyclosporine-A
•14. Neuroendocrine tumours, not meeting the inclusion criteria:
•With known non-GEP-NET origin (e.g. pulmonary or gonadal
•Functional GE-NET
•Explicit diagnosis of unknown primary (CUP)
•G3 neuroendocrine tumours and neuroendocrine carcinomas
•NET for which no histological specimen for secondary histological
•analysis can be obtained
•15. Total hepatic tumour burden > 70%
•16. Brain metastases
•17. Other malignancy within previous 5 years (except basal cell carcinomas and in situ squamous cell carcinomas of the skin)
•18. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
•19.Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments, as follows:
•o Renal obstruction
•o Total bilirubin >1.5 x ULN
•o AST or ALT >2.5 x ULN
•o Alkaline phosphatase >5 x ULN
•o Albumin <3 g/dL, unless prothrombin time is within normal range
•Cardiovascular
•o New York Heart Association classification III and IV
•o Uncontrolled hypertension
•Haematopoietic
•o Platelets =80 × 109/L
•o Absolute neutrophil count (ANC) <1 x 109 cells/L
•20.Pregnant or breast-feeding women. Female patients of childbearing potential or male patients with female partners of childbearing potential, unless willing to practice full and true sexual abstinence or who are being surgically/permanently sterile (bilateral tubal occlusion, hysterectomy, or vasectomy), or female patients whose male partners have medically successful vasectomy (provided the partner is the sole sexual partner of the female patient of childbe

研究者

发起方

ITM Solucin GmbH

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