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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00688623
First received: May 30, 2008
Last updated: December 16, 2013
Last verified: December 2013
  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
Neuroendocrine
Non Functioning Neuroendocrine Tumors/NET
Non Syndromic Neuroendocrine Tumors/NET
Carcinoids
Non Functioning
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the disease control rate (CR + PR + SD) [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate progression-free survival in this patient population [ Time Frame: done as required at statisticla analysis ] [ Designated as safety issue: No ]
  • To evaluate overall survival in this patient population [ Time Frame: at date of last contact or at death ] [ Designated as safety issue: Yes ]
  • To further characterize the safety profile of RAD001 (Incidence of AEs) [ Time Frame: Every 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688623

Contacts
Contact: Novartis Pharmaceuticals +1-800-340-6843

Locations
France
Novartis Investigative Site Not yet recruiting
Bordeaux, France
Novartis Investigative Site Not yet recruiting
Lyon, France
Novartis Investigative Site Not yet recruiting
Marseille, France
Novartis Investigative Site Not yet recruiting
Paris, France
Germany
Novartis Investigative Site Recruiting
Bad Berka, Germany
Novartis Investigative Site Recruiting
Berlin, Germany
Novartis Investigative Site Not yet recruiting
Bonn, Germany
Novartis Investigative Site Not yet recruiting
Frankfurt, Germany
Novartis Investigative Site Recruiting
Heidelberg, Germany
Novartis Investigative Site Recruiting
Mainz, Germany
Novartis Investigative Site Not yet recruiting
Munich, Germany
Italy
Novartis Investigative Site Recruiting
Bologna, Italy
Novartis Investigative Site Recruiting
Milano, Italy
Novartis Investigative Site Not yet recruiting
Perugia, Italy
Novartis Investigative Site Recruiting
Perugia, Italy
Novartis Investigative Site Recruiting
Roma, Italy
Novartis Investigative Site Withdrawn
Roma, Italy
Novartis Investigative Site Recruiting
Viagrande, Italy
Netherlands
Novartis Investigative Site Recruiting
Rotterdam, Netherlands
Poland
Novartis Investigative Site Recruiting
Gdansk, Poland
Novartis Investigative Site Not yet recruiting
Warszawa, Poland
Spain
Novartis Investigative Site Withdrawn
Barcelona, Spain
Novartis Investigative Site Recruiting
Barcelona, Spain
Novartis Investigative Site Not yet recruiting
Madrid, Spain
Novartis Investigative Site Withdrawn
Malaga, Spain
Novartis Investigative Site Recruiting
Uppsala, Spain
Sweden
Novartis Investigative Site Not yet recruiting
Stockholm, Sweden
United Kingdom
Novartis Investigative Site Recruiting
Glasgow, United Kingdom
Novartis Investigative Site Withdrawn
London, United Kingdom
Novartis Investigative Site Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00688623     History of Changes
Other Study ID Numbers: CRAD001CDE16
Study First Received: May 30, 2008
Last Updated: December 16, 2013
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Italy: Agenzia Italiana del Farmaco (AIFA)
Netherlands: De Centrale Commissie Mensgebonden Onderzoek (CCMO)
Poland: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Spain: Agencia Española del Medicamento
Sweden: Läkemedelsverket
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Neuroendocrine tumors
non-functioning neuroendocrine tumors carcinoids
non-functioning carcinoids
adults
everolimus

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

ClinicalTrials.gov processed this record on September 29, 2014