NCT01886287

P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.

Detailed description

The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary). All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide, or until resolution or stabilization of the event, whichever comes first.

Conditions

• Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Octreotide LAR	Octreotide LAR as outlined in Treatment Arm.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2013-06-25
• Last updated: 2015-01-12
• Results posted: 2015-01-12

Locations

1 site across 1 country: United States