EUCTR2015-001467-39-ES
Active, not recruiting
Not Applicable
A phase II study to evaluate the safety and efficacy of lenvatinib in patients with advanced grade 1/2 neuroendocrine neoplasmas of pancreatic and extrapancreatic origin. - TALENT
GETNE (Grupo Español de Tumores Neuroendocrinos)0 sites110 target enrollmentJuly 10, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GETNE (Grupo Español de Tumores Neuroendocrinos)
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects must have histologically confirmed diagnosis of one of the following advanced/metastatic neuroendocrine tumor types:
- •a)WHO Classification G1/G2 (Ki67\<20% and mitotic count ?20 mitoses x 10 HPF) pancreatic neuroendocrine tumor
- •b)WHO Classification G1/G2 (Ki67\<20% and mitotic count ?20 mitoses x 10 HPF) gastrointestinal neuroendocrine tumor (including stomach, small intestine and colorectal origins).
- •2\.Subjects must have evidence of measurable
- •3\.Subjects must show evidence of disease progression by radiologic image techniques within 12 months prior to signing informed consent, according to RECIST 1\.1 (Appendix I).
- •4\.Subjects must meet the following inclusion criterion regarding primary tumor site:
- •a)Pancreatic origin:
- •b)Gastrointestinal origin:
- •5\. Only for patients with pancreatic origin neuroendocrine tumors, one previous line with chemotherapy is allowed.
- •6\.Concomitant somatostatin analogues are allowed in both cohorts during the study.
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from this study:
- •1\.WHO Classification G3 neuroendocrine tumors of the pancreas and gastrointestinal tract.
- •2\.Two or more prior lines of targeted agents\-based therapy in pancreatic origin and any previous line of targeted therapy for gastrointestinal origin or any ongoing antiproliferative treatment for advanced/metastatic neuroendocrine tumors, with the exception of somatostatin analogues therapy.
- •3\.More than one previous line of chemotherapy in pancreatic neuroendocrine tumors.
- •4\.Previous chemotherapy in gastrointestinal neuroendocrine tumors.
- •5\.Prior treatment with lenvatinib.
- •6\.Subjects who have received any anti\-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anti\-cancer treatment. This does not apply to the use of somatostatin analogues for symptomatic therapy.
- •7\.Major surgery within 3 weeks prior to the first dose of study drug.
- •8\.Subjects having \> 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.
- •9\.Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib.
Outcomes
Primary Outcomes
Not specified
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