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: 2015-10-01
• 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: 2020-08-01
• Results First Submitted: 2022-01-11
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Results First Posted: 2025-07-24
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment	Up to 18 months	Data cut-off for the primary study analysis will happen following after the 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.; Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR.
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
Number of Participants With Early Tumor Shrinkage (ETS)	Up to 18 months	To calculate early tumor shrinkage (ETS) rate, patients were classified as responders/non-responders after a period of 6 weeks (first post-baseline tumor assessment). Those who achieved a 20% reduction in target lesions after the first 6 weeks of treatment were classified as responders.
Tumour Shrinkage	18 months	Number of patients that exhibited a deepness of response lower than 0%.
Deepness of Response (DpR)	Up to 18 months	(DpR) defined as percentage of maximum tumor shrinkage observed at the nadir compared with baseline
Progression-free Survival (PFS)	Up to 18 months	Progression-free survival (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

Scroll for more (12 remaining)