Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Not provided
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
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Azienda Ospedaliero Universitaria Careggi - SC di Oncologia
🇮🇹Firenze, Italy
Hospital Universitario Vall Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
IRCCS Napoli
🇮🇹Napoli, Italy
Hospital Universatorio de Verona
🇮🇹Verona, Italy
IRST of Meldola
🇮🇹Meldola, Italy
ICO Hospitalet
🇪🇸L´Hospitalet de Llobregat, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital de Donostia
🇪🇸Donostia, País Vasco, Spain
Instituto Oncologico Mediterraneo
🇮🇹Catania, Italy
AOU Policlinico di Modena - DH Oncologico
🇮🇹Modena, Italy
Hospital Universitario la Paz
🇪🇸Madrid, Spain
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Istituto Europeo di Oncologia - Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
🇮🇹Milano, Italy
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Andalucía, Spain
Beatson Oncology Centre Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom
Christie Hospital, Manchester
🇬🇧Manchester, United Kingdom
Hospital Miguel Servet
🇪🇸Zaragoza, Spain