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Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01595009
First received: May 7, 2012
Last updated: March 21, 2017
Last verified: March 2017
  Purpose

To provide everolimus to patients with p-NET, GI or lung NETs before potential everolimus approval, the expanded access study CRAD001K24133 was designed to provide treatment until disease progression or unacceptable toxicity or until 30 May 2012, whichever occurs first. In this study, 60 patients with GI or lung NETs were enrolled in Germany and there are still approximately 40 patients benefiting from everolimus treatment.

To provide the study medication to these patients beyond 30 May 2012, this open label extension will allow those patients who have been experiencing clinical benefit from everolimus treatment and who did not suffer from unacceptable toxicity to continue to receive treatment with the therapy until disease progression, unacceptable toxicity, or until study end on 31 May 2014, whichever comes first. Patients will be followed for safety and tolerability and for efficacy of everolimus.


Condition Intervention Phase
Neuroendocrine Tumors Drug: RAD001 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Number of participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 2 years ]

Secondary Outcome Measures:
  • Investigator-assessed Progression Free Survival (PFS) [ Time Frame: up to 2 years ]
  • Quality of Life [ Time Frame: up to 2 years ]

Enrollment: 15
Actual Study Start Date: June 19, 2012
Study Completion Date: August 9, 2016
Primary Completion Date: August 9, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: RAD001

  Eligibility

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

Inclusion and Exclusion Criteria:

  • The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
  • Age ≥18 years old
  • Completion of the whole treatment period in the CRAD001K24133 study
  • Neuroendocrine tumor of gastrointestinal or pulmonary origin (pancreatic neuroendocrine tumors are excluded)
  • No tumor progression during therapy with everolimus during CRAD001K24133 study (checked via radiologically assessment)
  • No intolerable toxicity during therapy everolimus, or during combination therapy of everolimus and somatostatin analogues
  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: NCT01595009

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Chemnitz, Germany, 09113
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Homburg, Germany, 66421
Novartis Investigative Site
Kassel, Germany, 34125
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Muenchen, Germany, 81377
Novartis Investigative Site
Osnabrück, Germany, 49076
Novartis Investigative Site
Weiden, Germany, 92637
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01595009     History of Changes
Other Study ID Numbers: CRAD001K24133E1
Study First Received: May 7, 2012
Last Updated: March 21, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017