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Clinical Trial Summary

The study is designed as an open-label, prospective, single arm, multicenter study of everolimus in histologically confirmed, neuroendocrine carcinoma G3 /neuroendocrine tumor G3 after failure of first-line platin-based chemotherapy (open-label pilot study). The aim of this study is to provide a second line therapy to patients with any type of platinum based first line chemotherapy, to gather data on disease control rate and progression free survival.


Clinical Trial Description

As more efficient drugs are urgently needed for the treatment of neuroendocrine tumors the investigator evaluated phosphorylated Mammalian target of rapamycin (mTOR) and effectors in a series of NEC G3 at the Charité Center. Everolimus showed antiproliferative effects in bronchial NET. In a second approach the data of this study should be the basis to generate another study to further explore everolimus as maintenance therapy in NEC G3/ NET G3. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Disease Progression
  • Neuroendocrine Carcinoma, Grade 1 [Well-differentiated Neuroendocrine Carcinoma] That Switched to G3
  • Neuroendocrine Carcinoma, Grade 2 [Moderately Differentiated Neuroendocrine Carcinoma] That Switched to G3
  • Neuroendocrine Carcinoma, Grade 3
  • Neuroendocrine Tumor, Grade 3 and Disease Progression as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.)
  • Neuroendocrine Tumors
  • Poorly Differentiated Malignant Neuroendocrine Carcinoma

NCT number NCT02113800
Study type Interventional
Source AIO-Studien-gGmbH
Contact
Status Completed
Phase Phase 2
Start date August 2015
Completion date April 2020

See also
  Status Clinical Trial Phase
Completed NCT03147404 - Phase II Study of Avelumab in Metastatic Gastronetro-pancreatic (GEP) Neuroendocrine Carcinoma (NEC, WHO Grade 3) as Second-line Treatment After Failing to Etoposide+Cisplatin: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes Phase 2