Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET
Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
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.