NCT03629847

Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

NET originate in neuroendocrine cells throughout the body. The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy as a 1st line therapy in unresectable well to moderately differentiated metastatic neuroendocrine tumors of all GI, lung and pancreatic origins. This is a phase 1 - 2 study. The phase 1 part involves finding the maximum tolerating dose (MTD) of Everolimus.

Detailed description

Neuroendocrine tumors NET refers to tumors that originate in neuroendocrine cells throughout the body (including in the thymus, lung, pancreas, gastrointestinal \[GI\] tract and less common sites). They can be broadly subclassified into well-differentiated and poorly differentiated cancers. Treatment of well differentiated NET are complex and involves surgical, Locoregional and systemic modalities depending on the manifestations as well as extent of disease. Treatment is best planned in a multidisciplinary tumor board. Of the emerging new systemic modalities are Everolimus and radiolabelled somatostatin analogue. The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy (a somatostatin analogue) as a first line therapy in unresectable well to moderately differentiated metastatic neuroendocrine tumors of all gastrointestinal, lung and pancreatic origins. This is a phase 1 - 2 study. The phase 1 part involves finding the maximum tolerating dose (MTD) of Everolimus.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Everolimus	Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2018-08-14
• Last updated: 2018-08-14

Locations

1 site across 1 country: Saudi Arabia