Trial to Assess the Efficacy of Lenvatinib in Metastatic Neuroendocrine Tumors. (TALENT STUDY)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 123
- Locations
- 22
- Primary Endpoint
- Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A
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)
Intervention: Lenvatinib (Drug)
Cohort B
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)
Intervention: Lenvatinib (Drug)
Outcomes
Primary Outcomes
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Time Frame: 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
Time Frame: 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 Outcomes
- Number of Participants With Early Tumor Shrinkage (ETS)(Up to 18 months)
- Tumour Shrinkage(18 months)
- Deepness of Response (DpR)(Up to 18 months)
- Progression-free Survival (PFS)(Up to 18 months)