RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe
NCT ID: NCT00688623
Last Updated: 2019-01-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2009-06-24
2016-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Everolimus
Everolimus
Everolimus
Everolimus 5 mg tablets were supplied in blister packs
Interventions
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Everolimus
Everolimus 5 mg tablets were supplied in blister packs
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Bad Berka, , Germany
Novartis Investigative Site
Bad Berka, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Munich, , Germany
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Viagrande, CT, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Perugia, PG, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Perugia, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
Viagrande, , Italy
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Uppsala, , Spain
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Glasgow - Scotland, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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CRAD001CDE16
Identifier Type: -
Identifier Source: org_study_id
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