Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors (MACS2074)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01595009
First received: May 7, 2012
Last updated: August 12, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator-assessed Progression Free Survival (PFS) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: RAD001

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, 09116
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01595009     History of Changes
Other Study ID Numbers: CRAD001K24133E1
Study First Received: May 7, 2012
Last Updated: August 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 19, 2014