Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.
The purpose of this study is to collect and assess long-term safety of everolimus in patients who are currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol and are unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study will be decided by Novartis. Investigator initiated trials (IITs) will not be included. The primary objective of the parent study must have been reached and the parent study must be in the process of being completed and reported.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of pariticipants with Adverse events as a measure of safety and tolerability [ Time Frame: From screening period to the end of the study (approximately 6 years) ] [ Designated as safety issue: Yes ]Long term safety. Frequency and nature of Adverse Events are to be collected.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Patients who are receiving everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol and are unable to access everolimus treatment outside of a clinical trial will be allowed to enroll.
Everolimus will be provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017860
|Contact: Novartis Pharmaceuticals||+81337978748|
|Contact: Novartis Pharmaceuticals|
|Novartis Investigative Site||Recruiting|
|Matsuyama, Ehime, Japan, 791-0280|
|Novartis Investigative Site||Not yet recruiting|
|Sapporo-city, Hokkaido, Japan, 060-8648|
|Novartis Investigative Site||Withdrawn|
|Chuo-ku, Tokyo, Japan|