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RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-Endocrine Tumors in Europe (RAMSETE/CDE16)
This study is not yet open for participant recruitment.
Verified by Novartis, December 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00688623
  Purpose

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


Condition Intervention Phase
Carcinoma, Neuro-Endocrine
Non Functioning Neuro-Endocrine Tumors/NET
Non Syndromic Neuro-Endocrine Tumors/NET
Carcinoids, Non Functioning
Drug: Everolimus
Phase II

MedlinePlus related topics: Cancer Carcinoid Tumors
Drug Information available for: Everolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-Endocrine Tumors

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Response Rate assessed by RECIST

Estimated Enrollment: 60
Study Start Date: December 2008
Arms Assigned Interventions
1: Experimental Drug: Everolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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 VEGF pathway inhibitor within 4 weeks prior to study entry
  5. Patients who entered 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688623

Contacts
Contact: Novartis 41 61 324 1111

Locations
France
Paris, France
Bordeaux, France
Lyon, France
Marseille, France
Germany
Frankfurt, Germany
Munich, Germany
Berlin, Germany
Bonn, Germany
Italy
Perugia, Italy
Milan, Italy
Rome, Italy
Poland
Warsaw, Poland
Spain
Barcelona, Spain
Madrid, Spain
Sweden
Stockholm, Sweden
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CRAD001CDE16
Study First Received: May 30, 2008
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00688623  
Health Authority: EU: EMEA

Keywords provided by Novartis:
Neuro-endocrine tumors, non functioning neuro-endocrine tumors, carcinoids, non functioning carcinoids, adults, everolimus

Study placed in the following topic categories:
Everolimus
Carcinoma, Neuroendocrine
Endocrine System Diseases
Carcinoma
Neuroendocrine Tumors
Carcinoid tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carcinoid Tumor
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009