Safety and Tolerability of Everolimus as Second-line Treatment in Poorly Differentiated Neuroendo… (NCT02113800) | Clinical Trial Compass
CompletedPhase 2
Safety and Tolerability of Everolimus as Second-line Treatment in Poorly Differentiated Neuroendocrine Carcinoma / Neuroendocrine Carcinoma G3 (WHO 2010) and Neuroendocrine Tumor G3 - an Investigator Initiated Phase II Study
Germany40 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent
✓. Male or female ≥ 18 years of age
✓. Patients with poorly differentiated neuroendocrine carcinoma, neuroendocrine carcinoma G3 (NEC - G3 according to WHO 2010) or well or moderately differentiated neuroendocrine carcinoma (NET - G1 / G2) that switched to G3 (confirmed by histology) or neuroendocrine tumor G3 (NET G3) and disease progression as measured by RECIST 1.1
✓. Progression during or after treatment with first-line platinbased chemotherapy. In NET G3 that switched from NET G2 the line of therapy is determined from the time of revised histology (confirming a G3 NEN)
✓. Measurable disease according to RECIST 1.1
✓. Performance Status according to Eastern Cooperative Oncology Group (ECOG) status 0 - 2 (Karnofsky Performance status ≥ 80%)
✓. Women of child-bearing potential must have a negative pregnancy test
. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their excipients.
✕. Previous therapy with mTOR inhibitor
✕. Radiotherapy :
✕. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
✕. Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
✕. Inadequate pulmonary function according to the Investigator's judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
✕. Known active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or HIV infection