NCT03083210

Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET

PILOT STUDY OF LANREOTIDE IN METASTATIC OR RECURRENT GRADE I-II HINDGUT NET

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Clinical data from uncontrolled retrospective or prospective studies have initially demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET patients, this is based on the results of CLARINET study, the largest prospective trial to evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries) with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67. The study had shown that treatment with lanreotide Autogel® significantly prolonged progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the primary analysis (median progression-free survival, not reached vs. 18.0 months, P\< 0.001 by the stratified log-rank test; hazard ratio for progression or death with lanreotide vs. placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) \[5\]. The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease. The addition of an indication for the treatment of patients with GEP-NETs has been approved by more than 15 other authorities including in Canada, Australia and some Asian countries, etc.

Detailed description

Patients with advanced hindgut NET who don't receive prior systemic therapies will receive laneotide. Study-arm is composed of 28 patients. Laneotide 120mg s.c. once every a 28 day.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Lanreotide	Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.

Timeline

• Start date: 2017-07-05
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-03-17
• Last updated: 2019-05-20

Locations

1 site across 1 country: South Korea