A prospective, randomised, Controlled, Open-label, Multicentre phase IIIstudy 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: 2021年1月7日最近更新: 2021年9月7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.DWritten informed consent
•2.DMale or female = 18 years of age
•3.DHistologically and clinically confirmed diagnosis of well- differentiated neuro-endocrine 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
•4.DAvailability of existing biopsy specimen from primary tumour or metastasis or, if unavailable, willingness to undergo current biopsy for secondary central analysis
•5.DMeasurable 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.DSomatostatin receptor positive (SSTR+) disease, as evidenced by
•SSTR imaging (SRI) within 4 months prior to randomisation, by:
•D68Ga-based SSTR PET imaging (e.g. using 68Ga-edotreotide or 68Ga- DOTATATE), or
•D111In-pentetreotide SSTR SPECT/planar imaging, or
•D99mTc-octreotide SSTR SPECT/planar imaging
•All target lesions and = 90% of non-target lesions need to be positive for SSTR, demonstrated by adequate tracer uptake, being defined as being clearly differentiable from background
•7.DRadiological disease progression, defined as:
•DProgressive disease per RECIST 1.1. criteria, evidenced by consecutive morphological imaging (CT or MRI) with = 90 days interval during the 12 months prior to randomisation
•8.DKarnofsky performance status (KPS) scale = 70
•9.DLife expectancy of at least 6 months
•10.DGlomerular filtration rate (GFR, MDRD) = 60 mL/min/1.73 m^2
•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

•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),
•5.Prior therapy with mTor inhibitors
•6.Prior EFR (extended field radiation) to GEP-NET lesions or radioembolisation therapy (e.g. 90Y microspheres,
•131I-lipiodol) with administration to the liver
•7.Therapy with an investigational compound and/or medical device within 30 days or 5 half-life periods (whichever is longer) prior to randomisation
•8.Subjects who have received a live vaccine up to 4 weeks prior to first dose
•9.Current therapy with any prohibited medication (see 6.1.1)
•10.Ongoing toxicity grade 2 according to CTCAE version 4.03 from previous standard or investigational therapies
•11.Indication for surgical lesion removal with curative potential
•12.Planned (for the period of study participation): chemotherapy, immunotherapy, radiation therapy, chemo-embolisation, bland embolisation, radio-embolisation, treatment with cyclosporine-A
•13.Neuroendocrine tumours, not meeting the inclusion criteria:
•With known non-GEP-NET origin (e.g. pulmonary or gonadal primaries)
•Functional GE-NET
•NET with unknown primaries (CUP), manifesting as liver metastases
•Poorly differentiated neuroendocrine carcinomas(G3)
•NET for which no histological specimen for secondary histological analysis can be obtained
•14.Total hepatic tumour burden > 70%
•15.Brain metastases
•16.Secondary malignoma within previous 5 years (except basalioma)
•17.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
•18.Renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments, as follows:
•oSerum potassium > 5.0 mmol/L
•oRenal obstruction
•oKnown nephropathy from any cause
•oTotal bilirubin > 1.5 x ULN
•oAST or ALT > 2.5 x ULN oDAlkaline phosphatase > 5 x ULN
•oAlbumin < 3 g/dL, unless prothrombin time is within normal range oKnown cirrhosis or other distinctly restricted liver function
•Cardiovascular
•oNew York Heart Association classification III & IV
•oUncontrolled hypertension
•Haematopoietic oPlatelets = 80 * 10^9/L
•o Absolute neutrophil count (ANC) < 1 x 10^9 cells/L
•19.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 being surgically/permanently sterile or with a history of hysterectomy for women, not willing to practice effective contraception by using: a non- oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, during the study period and for 56 days after treatment in the everolimus group and 66 days in the PRRT group (10 half-lives of 177Lu) after the last treatment cycle.
•20.Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).

研究者

发起方

ITM SOLUCIN GMBH

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