Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.

Phase 4

Completed

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

Detailed Description: This multi-center, open-label roll-over study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a Novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the Investigator.

The study was designed to provide continued treatment with everolimus monotherapy to the subjects. Subjects were allowed to continue combination therapy with Sandostatin LAR® Depot if they were receiving this combination therapy on the parent protocol. Subjects were allowed to continue in this roll-over study until they no longer benefitted from the everolimus treatment as judged by the Investigator, discontinued due to toxicities, subject withdrew consent or lost to follow-up, disease progression, protocol non-compliance, or subject death, whichever occurred first. A subject was considered to have reached end of study when everolimus treatment was permanently discontinued.

As per the original protocol, it was designed to collect only serious adverse events (SAEs) and protocol defined adverse events of special interest (AESIs). However, due to the feedback received from health authorities, the protocol was amended in 2016 (3 years after study was initiated) to collect all AEs (non-serious and serious AEs, and AESIs). The protocol was also amended to include an Investigator assessment of clinical benefit at every visit for remaining subjects.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

Subject was permanently discontinued from everolimus study treatment in the parent study.
Subject was receiving everolimus in combination with an unapproved or experimental treatment

Other protocol-defined inclusion/exclusion criteria might apply

Arm && Interventions

Group	Intervention	Description
Everolimus	Sandostatin LAR Depot	Participants 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.
Everolimus	Everolimus	Participants 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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Clinical Benefit	After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years	Percentage of patients with clinical benefit as judged by the investigator. Investigator attestation of continued clinical benefit was collected in clinical database after protocol amendment (release date 18 March 2016). Clinical benefit assessment before protocol amendment was done retrospectively.

Locations (14): New York University Medical Center SC-4
🇺🇸
New York, New York, United States
H Lee Moffitt Cancer Center and Research Institute SC-2
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Tampa, Florida, United States
Rocky Mountain Cancer Centers SC
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Greenwood Village, Colorado, United States
Crescent City Research Consortium, LLC SC-3
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Metairie, Louisiana, United States
Hematology Oncology Services of Arkansas SC
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Little Rock, Arkansas, United States
Oregon Health and Science University SC-8
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Portland, Oregon, United States
Novartis Investigative Site
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Izmir, Turkey
Nebraska Cancer Specialists Onc Dept
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Omaha, Nebraska, United States
Utah Cancer Specialists Utah Cancer (2)
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Salt Lake City, Utah, United States
Washington University School of Medicine Dept of Oncology
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Saint Louis, Missouri, United States
Stamford Hospital
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Stamford, Connecticut, United States
Central Indiana Cancer Centers SC
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Indianapolis, Indiana, United States
Clinical Research Alliance
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Lake Success, New York, United States
Mayo Clinic SC-2
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Rochester, Minnesota, United States