Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors (MACS2074)
This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01595009
First received: May 7, 2012
Last updated: January 9, 2013
Last verified: January 2013
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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: 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RAD001 | Drug: RAD001 |
Eligibility| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595009
Contacts
| Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
Locations
| Germany | |
| Novartis Investigative Site | Withdrawn |
| Mannheim, Baden-Württemberg, Germany, 68305 | |
| Novartis Investigative Site | Recruiting |
| Berlin, Germany, 13353 | |
| Novartis Investigative Site | Recruiting |
| Berlin, Germany, 10098 | |
| Novartis Investigative Site | Recruiting |
| Chemnitz, Germany, 09116 | |
| Novartis Investigative Site | Recruiting |
| Erlangen, Germany, 91054 | |
| Novartis Investigative Site | Recruiting |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | Withdrawn |
| Freiburg, Germany, 79106 | |
| Novartis Investigative Site | Recruiting |
| Homburg, Germany, 66421 | |
| Novartis Investigative Site | Recruiting |
| Kassel, Germany, 34125 | |
| Novartis Investigative Site | Withdrawn |
| Magdeburg, Germany, 39120 | |
| Novartis Investigative Site | Recruiting |
| Mainz, Germany, D-55101 | |
| Novartis Investigative Site | Active, not recruiting |
| Muenchen, Germany, 81377 | |
| Novartis Investigative Site | Recruiting |
| Osnabrück, Germany, 49076 | |
| Novartis Investigative Site | Recruiting |
| 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: | January 9, 2013 |
| 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 |
Everolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013