EUCTR2012-004550-28-DE
Active, not recruiting
Phase 1
EVINEC: Safety and Tolerability of Everolimus as second-line treatment in poorly differentiated neuroendocrine carcinoma / neuroendocrine carcinoma G3 according to WHO 2010 and neuroendocrine tumor G3 - an investigtor initiated Phase II study. - EVINEC
Conditions• Poorly differentiated neuroendocrine carcinoma, neuroendocrine carcinoma G3 (NEC G3 according to WHO 2010) with primary tumor outside lung• Well to moderately differentiated neuroendocrine carcinoma (NET G1/G2) that switched to G3 (confirmed by histology)• Neuroendocrine tumor G3 (NET G3)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- • Poorly differentiated neuroendocrine carcinoma, neuroendocrine carcinoma G3 (NEC G3 according to WHO 2010) with primary tumor outside lung• Well to moderately differentiated neuroendocrine carcinoma (NET G1/G2) that switched to G3 (confirmed by histology)• Neuroendocrine tumor G3 (NET G3)
- Sponsor
- AIO-Studien-gGmbH
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed written informed consent
- •2\. Male or female \=18 years of age
- •3\. 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
- •4\. Progression during or after treatment with first\-line platin\-based chemotherapy. In NET G3 that switched from NET G2 the line of therapy is determined from time of revised histology (confirming a G3 NEN)
- •5\. Measurable disease according to RECIST 1\.1
- •6\. ECOG status 0\-2 (Karnofsky Performance status \=80%)
- •7\. Women of child\-bearing potential must have a negative pregnancy test
- •8\. Laboratory requirements:
- •Hematology
- •o Absolute neutrophil count \=1\.5x10^9/L
Exclusion Criteria
- •1\. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their exipients.
- •2\. Previous therapy with mTOR inhibitor
- •3\.Radiotherapy :
- •Concurrent radiotherapy involving target lesions used for this study.
- •Concurrent palliative radiation (but radiation for non\-target lesions is allowed if other target lesions are available outside the involved field)
- •previous pre\-operative or post\-operative radiotherapy within 3 months before study treatment
- •4\. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
- •5\. Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- •6\. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \=1year before enrolment
- •7\. 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
Outcomes
Primary Outcomes
Not specified
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