Phase 2
N=111
Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors
Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02678780 ↗Enrolled (actual)
111
Serious AEs
42.3%
Results posted
Jul 2025
Primary outcome: Primary: Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment — 0; 0; 23; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenvatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment |
0; 0; 23; 9; 27; 42 | — |
| PRIMARY Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment |
44.23; 16.36 | — |
| SECONDARY Progression-free Survival (PFS) |
12; 12; 34; 36; 5; 7 | — |
| SECONDARY Number of Participants With Early Tumor Shrinkage (ETS) |
32; 46; 20; 5 | — |
| SECONDARY Deepness of Response (DpR) |
-26.28; -15.34 | — |
| SECONDARY Tumour Shrinkage |
6; 6; 46; 46 | — |
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).
Eligibility Criteria
INCLUSION CRITERIA
Subjects must meet all of the following criteria to be included in this study:
- Subjects must have histologically confirmed diagnosis of one of the following advanced/metastatic neuroendocrine tumor types:
- WHO Classification G1/G2 (Ki67 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24h will be ineligible.
- Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months prior to the first dose of study drug, or cardiac arrhythmia requiring medical treatment. The left ventricular ejection fraction in the echocardiogram must be of at least 50%.
- Prolongation of QTcF interval to > 480 msec.
- Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. Treatment with low molecular weight heparin (LMWH) is allowed.
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- Active infection (any infection requiring treatment).
- Active malignancy within the past 5 years (except for definitely treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix).
- Known intolerance or hypersensitivity to the active substance (or any of the excipients).
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
- Females who are pregnant or breastfeeding.
- Documented active alcohol or drug abuse.
- Patients with a prior history of non-compliance with medical regimens.
Data sourced from ClinicalTrials.gov (NCT02678780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.