Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: Lenvatinib

• Registration Number: NCT02678780
• Lead Sponsor: Grupo Espanol de Tumores Neuroendocrinos

Brief Summary

This is a prospective, international, multi-center, open label, stratified, exploratory phase II study evaluating the efficacy and safety of lenvatinib in patients with advanced/metastatic, neuroendocrine tumors of the pancreas after progression to a previous targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin analogues (cohort B).

Detailed Description

Trial to assess the efficacy of Lenvatinib in metastatic neuroendocrine tumor. The primary endpoint of the study is overall response rate (ORR) by RECIST v 1.1 upon central radiologic assessment.

Number of patients: 110 patients Estimated duration of subject participation: 24 months

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Primary Completion: 2017-12
• Study Completion: 2020-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B	Lenvatinib	Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Cohort A	Lenvatinib	Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent. Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR) by RECIST v 1.1 upon central radiologic assessment	Up to 18 months	Data cut-off for the primary study analysis will happen following after th e last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy

Secondary Outcome Measures

Name	Time	Method
Deepness of response (DpR)	Up to 18 months	(DpR) defined as percentage of maximum tumor shrinkage observed at the nadir compared with baseline
Early tumor shrinkage (ETS) rate	Up to 18 months	(ETS) rate defined as 20% reduction in target lesions after the first 6 weeks of treatment (first tumor assessment)
Progression-free survival (PFS)	Up to 18 months	(PFS) is defined as the time from the date of treatment start (C1D1)to the date of first documentation of disease progression or death (whichever Occurs first) using RECIST 1.1. PFS censoring rules will follow FDA guidance in 2007

Trial Locations

Locations (22)

Universitätsklinik für Innere Medizin; 🇦🇹 Graz, Austria

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Instituto Oncologico Mediterraneo; 🇮🇹 Catania, Italy

Azienda Ospedaliero Universitaria Careggi - SC di Oncologia; 🇮🇹 Firenze, Italy

IRST of Meldola; 🇮🇹 Meldola, Italy

Istituto Europeo di Oncologia - Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini; 🇮🇹 Milano, Italy

AOU Policlinico di Modena - DH Oncologico; 🇮🇹 Modena, Italy

IRCCS Napoli; 🇮🇹 Napoli, Italy

Hospital Universatorio de Verona; 🇮🇹 Verona, Italy

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