RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
Condition: Advanced and Metastatic Silent Neuro-Endocrine Tumors; Carcinoma; Neuroendocrine; Non Functioning Neuroendocrine Tumors (NETs); Non Syndromic Neuroendocrine Tumors; Carcinoids; Non Functioning
MeSH terms: Neoplasms; Neuroendocrine Tumors; Carcinoid Tumor; Endocrine Gland Neoplasms
Intervention: Everolimus
Intervention description: Everolimus 5 mg tablets were supplied in blister packs
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuroendocrine tumors; non functioning neuroendocrine tumors; Non syndromic neuroendocrine tumors; carcinoids; non-functioning carcinoids; adults; everolimus; NET; RAMSETE; CRAD001; non-functioning neuroendocrine tumors carcinoids

Summary:

      To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line
      treatment of patients with metastatic papillary carcinoma of the kidney.
    

Eligibility criteria:

        Inclusion criteria:

          1. ≥ 18 years old

          2. Patients with advanced (unresectable or metastatic) biopsy proven non-syndromic
             neuro-endocrine carcinoma, low or intermediate grade

          3. Radiological documentation of disease progression within 12 months prior to study
             entry. If patients received anti-tumor therapy during the past 12 months, they must
             have radiological documentation of progressive disease (PD) while on or after
             receiving the therapy

          4. Patients may have received previous treatments (chemotherapy, biotherapy,
             peptide-receptor radionuclide therapy); an overall maximum of 3 systemic treatment is
             allowed

          5. Patients with at least one measurable lesion

          6. Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2

          7. Adequate bone marrow function

          8. Adequate liver function

          9. Adequate renal function

         10. Adequate lipid profile

        Exclusion criteria:

          1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade
             neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell
             carcinoma

          2. Patients with carcinoid with hormone related symptoms (diarrhea ≥ 4 stools per day
             and/or flushes)

          3. Patients with Islet cell carcinomas or pancreatic NET

          4. Patients who received prior therapy with Vascular Endothelial Growth Factor (VEGF)
             pathway inhibitor within 4 weeks prior to study entry

          5. Patients who entered peptide receptor radionuclide therapy (PRRT) within 3 months
             prior to study entry

          6. Patients who received CT, biotherapy or radiotherapy within 4 weeks prior to study
             entry

          7. Patients who have previously received systemic (mammalian target of rapamycin) mTOR
             inhibitors

          8. Patients with a known hypersensitivity to everolimus or other rapamycins or to its
             excipients

          9. Patients with uncontrolled central nervous system (CNS) metastases

         10. Patients receiving chronic systemic treatment with corticosteroids or another
             immunosuppressive agent

         11. Patients with a known history of HIV seropositivity

         12. Patients with autoimmune hepatitis

         13. Patients with an active, bleeding diathesis

         14. Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study

         15. Patients who have a history of another primary malignancy and off treatment ≤ 3 years,
             with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine
             cervix

         16. Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods

         17. Patients who are using other investigational agents or who had received
             investigational drugs ≤ 4 weeks prior to study treatment start

         18. Patients unwilling to or unable to comply with the protocol