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

Status

Status unknown

Phase

Phase 4

Enrollment

28 participants (estimated)

Sponsor

Samsung Medical Center · Other

Design

Allocation not applicable · Open label (no masking)

Countries

1 country

South Korea

Start

5 Jul 2017

Primary completion

Feb 2020 (estimated)

Completion

Feb 2020 (estimated)

First posted

17 Mar 2017

Last update posted

20 May 2019

Conditions

Neuroendocrine Tumors

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.

• Experimental

  Lanreotide

  Lanreotide, at a dose of 120mg will be administered without dose adjustment, by means of deep subcutaneous injection every 28 days.

1. Progression free survival

   Time frame · up to 12 months

No study cites this trial.