Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
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
2 other identifiers
interventional
34
9 countries
24
Brief Summary
Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2013
Longer than P75 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedStudy Start
First participant enrolled
May 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedResults Posted
Study results publicly available
June 11, 2021
CompletedJune 11, 2021
May 1, 2021
7.3 years
February 7, 2013
May 17, 2021
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately.
SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years
Secondary Outcomes (1)
Percentage of Patients With Clinical Benefit
After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years
Study Arms (1)
Everolimus
EXPERIMENTALParticipants who were receiving everolimus in a Novartis-sponsored study, were not progressing on the current study treatment and were unable to access everolimus treatment outside of a clinical trial. Participants receiving everolimus treatment in combination with Sandostatin LAR Depot on the parent protocol were allowed to continue Sandostatin LAR Depot treatment.
Interventions
Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.
Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.
Eligibility Criteria
You may qualify if:
- Subject enrolled in a Novartis-sponsored, CD\&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the parent study
- Subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.
You may not qualify if:
- Subject was permanently discontinued from everolimus study treatment in the parent study.
- Subject was receiving everolimus in combination with an unapproved or experimental treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Hematology Oncology Services of Arkansas SC
Little Rock, Arkansas, 72205, United States
Rocky Mountain Cancer Centers SC
Greenwood Village, Colorado, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
H Lee Moffitt Cancer Center and Research Institute SC-2
Tampa, Florida, 33612, United States
Central Indiana Cancer Centers SC
Indianapolis, Indiana, 46227, United States
Crescent City Research Consortium, LLC SC-3
Metairie, Louisiana, 70006, United States
Mayo Clinic SC-2
Rochester, Minnesota, 55905, United States
Washington University School of Medicine Dept of Oncology
St Louis, Missouri, 63110, United States
Nebraska Cancer Specialists Onc Dept
Omaha, Nebraska, 68154, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
New York University Medical Center SC-4
New York, New York, 10016, United States
Oregon Health and Science University SC-8
Portland, Oregon, 97239, United States
Utah Cancer Specialists Utah Cancer (2)
Salt Lake City, Utah, 84106, United States
Novartis Investigative Site
Prague, Czech Republic, 120 00, Czechia
Novartis Investigative Site
Arezzo, AR, 52100, Italy
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Milan, MI, 20141, Italy
Novartis Investigative Site
Groningen, 9713 GZ, Netherlands
Novartis Investigative Site
Leningrad Region, Russia, 188663, Russia
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Bangkok, 10700, Thailand
Novartis Investigative Site
Izmir, 35040, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The original protocol was designed to collect only SAEs and protocol defined AESIs in the Safety database. The protocol was amended in 2016 (3 years after study was initiated) to include all AEs (non-SAEs, SAEs, and AESIs) to be collected in the clinical database. At the time of amendment release, 32 of the 34 subjects were enrolled and did not have AEs collected in clinical database before protocol amendment, which also amounts to approximately 50% of SAEs not reported in clinical database.
Results Point of Contact
- Title
- Study director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2013
First Posted
February 12, 2013
Study Start
May 14, 2013
Primary Completion
August 28, 2020
Study Completion
August 28, 2020
Last Updated
June 11, 2021
Results First Posted
June 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.