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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789281
• Other study ID #: CRAD001C2X01B
• Secondary ID: 2012-004707-12
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2013
• Est. completion date: August 28, 2020

Study information

• Verified date: May 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Everolimus
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
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.

Locations

Country	Name	City	State
Czechia	Novartis Investigative Site	Praha 2	Czech Republic
Italy	Novartis Investigative Site	Arezzo	AR
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Groningen
Russian Federation	Novartis Investigative Site	Leningrad Region	Russia
Spain	Novartis Investigative Site	Barcelona	Catalunya
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Izmir
United States	Rocky Mountain Cancer Centers SC	Greenwood Village	Colorado
United States	Central Indiana Cancer Centers SC	Indianapolis	Indiana
United States	Clinical Research Alliance	Lake Success	New York
United States	Hematology Oncology Services of Arkansas SC	Little Rock	Arkansas
United States	Crescent City Research Consortium, LLC SC-3	Metairie	Louisiana
United States	New York University Medical Center SC-4	New York	New York
United States	Nebraska Cancer Specialists Onc Dept	Omaha	Nebraska
United States	Oregon Health and Science University SC-8	Portland	Oregon
United States	Mayo Clinic SC-2	Rochester	Minnesota
United States	Washington University School of Medicine Dept of Oncology	Saint Louis	Missouri
United States	Utah Cancer Specialists Utah Cancer (2)	Salt Lake City	Utah
United States	Stamford Hospital	Stamford	Connecticut
United States	H Lee Moffitt Cancer Center and Research Institute SC-2	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czechia,  Italy,  Korea, Republic of,  Netherlands,  Russian Federation,  Spain,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients With Clinical Benefit	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.	After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years