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Biomarker identification of radionuclide therapy-induced radiation responses.

This is a pilot study to validate the possibility of determining the effect of PRRT with 177Lu-DOTATATE on transcriptional regulation and DNA damage induction in PBMCs and how this is related to the radiation dose.We will also want to explore if we…

An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations.

Primary objective: To determine the antitumor activity regarding objective response rate (ORR) of tipifarnib in subjects with locally advanced non-resectable or metastatic, relapsed and/or refractory, non-haematological malignancies with HRAS…

A Phase 3, Multicenter, Open-label, Randomized Study of nab®-Paclitaxel Plus Gemcitabine versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma

Primary Objective- The primary objective of the study is: * to compare DFS between subjects randomized to nabpaclitaxel plus gemcitabine and subjects randomized to gemcitabine alone.Secondary Objectives- The secondary objectives of the study are to…

An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy

To determine the objective response rate (ORR) (complete response and partialresponse) of RAD001 10 mg po qd monotherapy in patients with advanced(unresectable or metastatic) pancreatic NET after the failure of cytotoxicchemotherapy.

A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 and Grade 3 advanced GEP-NET

This study has been transitioned to CTIS with ID 2023-507443-10-00 check the CTIS register for the current data. The pivotal Phase III NETTER-1 study showed that Lutathera with best supportive care (30mg octreotide long-acting) provided a…

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient- reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

This study has been transitioned to CTIS with ID 2024-510812-64-00 check the CTIS register for the current data. The purpose of this study is to investigate the efficacy and safety of the investigational drug known as Lutetium (177Lu) edotreotide in…

Treatment with Recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with Anaplastic Thyroid Cancer: a proof of concept study

To investigate the efficacy of treatment with human recombinant IL1Ra (rhIL1Ra, Anakinra) in patients with ATC in terms of improved health related quality of life (HRQoL), tumor progression and Overall Survival (OS). Secondary objectives: To…

An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with well-differentiated advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gasteroenteropancreatic neuroendocrine carcinoma (GEP-NEC) who have progressed on prior treatment (CPDR001E2201)

Primary: To estimate the antitumor activity (assessed as overall response rate) of PDR001 as a single agent in patients with non-functional neuro-endocrine tumors (NET).Secondary: To estimate efficacy (duration of response) of PDR001. Safety and…