RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe (RAMSETE/CDE16)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688623
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma Neuroendocrine Non Functioning Neuroendocrine Tumors/NET Non Syndromic Neuroendocrine Tumors/NET Carcinoids Non Functioning Drug: Everolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 24, 2009
Actual Primary Completion Date : November 7, 2016
Actual Study Completion Date : November 7, 2016

Arm Intervention/treatment
Experimental: Everolimus
Drug: Everolimus

Primary Outcome Measures :
  1. To evaluate the efficacy of RAD001 as monotherapy in patients with non syndromic neuro-endocrine tumours (NET). Efficacy is defined as the proportion of patients with complete (CR) or partial response (PR) according to RECIST criteria. [ Time Frame: At baseline, Every 12 weeks, at end of study treatment ]

Secondary Outcome Measures :
  1. To evaluate the disease control rate (CR + PR + SD) [ Time Frame: Every 12 weeks ]
  2. To evaluate the biochemical response rate based on the tumour marker CgA [ Time Frame: At baseline, Every 28 days or every 12 weeks, at end of study treatment ]
  3. To evaluate progression-free survival in this patient population [ Time Frame: done as required at statisticla analysis ]
  4. To evaluate overall survival in this patient population [ Time Frame: at date of last contact or at death ]
  5. To further characterize the safety profile of RAD001 (Incidence of AEs) [ Time Frame: Every 28 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688623

Novartis Investigative Site
Bad Berka, Germany, 99438
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Viagrande, CT, Italy, 95029
Novartis Investigative Site
Roma, RM, Italy, 00189
Novartis Investigative Site
Gdansk, Poland, 80-952
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08907
Novartis Investigative Site
Barcelona, Cataluña, Spain
United Kingdom
Novartis Investigative Site
Glasgow - Scotland, United Kingdom, G12 OYN
Novartis Investigative Site
Manchester, United Kingdom, M20 9BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00688623     History of Changes
Other Study ID Numbers: CRAD001CDE16
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Neuroendocrine tumors
non-functioning neuroendocrine tumors carcinoids
non-functioning carcinoids

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Endocrine Gland Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Endocrine System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents