Safety and efficacy of lanreotide autogel/depot (LAN) every 14 days for patients with pancreatic or midgut neuroendocrine tumours (NETs) progressing on LAN every 28 days: The prospective, international CLARINET FORTE study

Background

The CLARINET study demonstrated the antitumor effect of lanreotide autogel/depot (LAN) vs. placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumours (NETs) and reaffirmed its favourable safety profile. Patients with progressive disease (PD) receiving LAN 120 mg every 28 days (standard dosing interval) are usually offered aggressive treatments (chemotherapy, targeted therapies, or peptide receptor radionuclide therapy). The CLARINET FORTE study will investigate the safety and antitumour efficacy of a reduced dosing interval (every 14 days) of LAN 120 mg in patients with pancreatic or midgut NETs, beyond progression on the standard dosing interval.

Trial design

CLARINET FORTE is an international, multicentre, prospective, open label phase II study. Main eligibility criteria: adult patients with well-differentiated, metastatic or locally advanced, unresectable, functioning or non-functioning, G1/G2, pancreatic NETs (pNETs) or midgut NETs. Patients will have radiological PD, within 24 months prior to enrolment, as assessed by an independent central review according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, while receiving first line treatment with LAN 120 mg on standard dosing intervals (ECOG PS 0-2). It is planned to enrol a total of 100 patients, 50 per cohort (pNETs or midgut NETs) in a total of 30–35 sites in Europe and the USA. LAN will be administered by deep subcutaneous injection at a dose of 120 mg every 14 days up to 48 weeks or 96 weeks for the pNET or midgut NET cohorts, respectively, or until PD/death or early withdrawal due to unacceptable toxicity/tolerability. The primary endpoint is progression-free survival (PFS), based on central review according to RECIST v1.0. Secondary endpoints include overall survival, objective radiologic response rate, effect on symptoms, quality of life, LAN pharmacokinetics, and safety. Analyses will be descriptive and p-values will be provided only for exploratory purposes. As of May 9^th 2016, 3 patients were enrolled in the study.

Clinical trial identification

EudraCT 2014-005607-24; Clinical Trials.gov: NCT02651987.

Legal entity responsible for the study

Ipsen

Funding

Ipsen

Disclosure

M. Pavel: Research funding from Novartis. Consulting/advisory fees from Ipsen, Novartis, Pfizer and Lexicon. C. Dromain: Consulting/advisory fees from Ipsen. C. Massien, A. Houchard: Employee of Ipsen.