Clinical trial NCT01789281: Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Keywords: Neoplasms
Carcinoid tumor
Neuroendocrine tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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:
measure: Percentage of Patients With Clinical Benefit
timeFrame: After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas SC
state: Arkansas
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers SC
state: Colorado
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute SC-2
state: Florida
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers SC
state: Indiana
city: Metairie
country: United States
facility: Crescent City Research Consortium, LLC SC-3
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic SC-2
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine Dept of Oncology
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists Onc Dept
state: Nebraska
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: New York University Medical Center SC-4
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University SC-8
state: Oregon
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Utah Cancer (2)
state: Utah
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Leningrad Region
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: