NCT01253161

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

Detailed description

This is a multi-institutional, prospective phase II open-label trial. The investigational drug used in this study is pasireotide LAR 60 mg. Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent. Safety and efficacy will be assessed throughout the treatment period.

Conditions

• Neuroendocrine Tumors
• Carcinoid Tumors

Interventions

Type	Name	Description
DRUG	Pasireotide Long Acting Release (LAR)	Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2011-02-01
• Primary completion: 2021-10-06
• Completion: 2023-03-02
• First posted: 2010-12-03
• Last updated: 2023-03-06
• Results posted: 2022-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study