An Open-label, Multi-center Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study and Are Judged by the Investigator to Benefit From Continued Everolimus Treatment
Phase 4
N/A
N/A
N/A
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
An Open-label, Multi-center Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study and Are Judged by the Investigator to Benefit From Continued Everolimus Treatment
Inclusion Criteria:
- Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving
everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their
requirements in the parent study
- Patient is currently benefiting from treatment with everolimus, as determined by the
guidelines of the parent protocol.
Exclusion Criteria:
- Patient has been permanently discontinued from everolimus study treatment in the
parent study.
- Patient is receiving everolimus in combination with an unapproved or experimental
treatment
- Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients receiving everolimus
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001C2X01B
NCT ID:
NCT01789281
Start Date:
March 2013
Completion Date:
June 2022
Related Keywords:
- Neoplasms
- Neoplasms, Carcinoid tumor, Neuroendocrine tumor
- Neoplasms
Name | Location |
|---|---|
| Stamford Hospital | Stamford, Connecticut 06904 |
| US Oncology Central Monitoring | Dallas, Texas 75246 |
| Hematology Oncology Services of Arkansas SC | Little Rock, Arkansas 72205 |
| Rocky Mountain Cancer Centers SC | Greenwood Village, Colorado |
| Central Indiana Cancer Centers SC | Indianapolis, Indiana 46227 |
| Washington University School Of Medicine-Siteman Cancer Ctr Dept of Oncology | St. Louis, Missouri 63110 |
| Virginia Oncology Associates SC | Norfolk, Virginia 23502 |
