Powder and solvent for suspension for injectionĮ.1 Medical condition or disease under investigation Sandostatin® LAR® powder and solvent for suspension for injection Sandostatin® LAR® 30 mg powder and solvent for suspension for injection Sandostatin® LAR® 20 mg powder and solvent for suspension for injection Sandostatin® LAR® 10 mg powder and solvent for suspension for injection Medicinal product containing genetically modified organisms Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)ġ77Lu-DOTA0-Tyr3-Octreotate, lutetium Lu 177 dotatateĪctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. Name of the Marketing Authorisation holderĬountry which granted the Marketing Authorisation Lutathera 370 MBq/mL solution for infusion
TAC CON CONTRASTE TRIAL
IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanĮMA Decision number of Paediatric Investigation Plan Name or abbreviated title of the trial where available non-technical, languageĪ phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in combination with best supportive care octreotide long-acting (30 mg), when given as a 1st line treatment in GEP-NET patients with high proliferation rate tumors (G2 and G3), in comparison to treatment with high dose (60 mg) octreotide long-acting.Įstudio multicentro, aleatorizado y abierto en fase III para evaluar la eficacia y seguridad de Lutathera en combinación con el mejor tratamiento complementario, 30 mg de octreotida de acción prolongada, cuando se administra como tratamiento de primera línea en pacientes con TNE-GEP con un alto grado de proliferación (G2 y G3) en comparación con el tratamiento con una dosis alta (60 mg) de octreotida de acción prolongada. Title of the trial for lay people, in easily understood, i.e.
TAC CON CONTRASTE PLUS
This is a multicenter, stratified, randomized, open-label comparator-controlled, Phase III study in patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs, diagnosed within 6 months prior to screening, comparing treatment with Lutathera (7.4GBq/200 mCi x 4 administrations every 8± 1 weeks cumulative dose: 29.6 GBq/800mCi) plus octreotide long-acting (30 mg every 8 weeks during Lutathera treatment and every 4 weeks after last Lutathera treatment) and high dose octreotide long-acting (60 mg every 4 weeks).Įste es un estudio multicéntrico, aleatorizado, abierto, estratificado y controlado con un comparador en fase III en pacientes con TNE-GEP avanzado, bien diferenciado, de Grado 2 y Grado 3 y receptor de somatostatina positivo, diagnosticado en los 6 meses anteriores a la selección, que comparará el tratamiento con Lutathera (7,4 GBq/200 mCi x 4 administraciones cada 8☑ semanas dosis acumulada: 29,6 GBq/800 mCi) más octreotida de acción prolongada (30 mg cada 8 semanas durante el tratamiento con Lutathera y cada 4 semanas después del último tratamiento con Lutathera) y una dosis alta de octreotida de acción prolongada (60 mg cada 4 semanas). Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on:
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