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 was to collect and assess long-term safety of everolimus in patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol, and were unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary objective of the parent study must have been reached and the parent study must have been in the process of being completed and reported.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Matsuyama, Ehime, Japan

About this study

This was a multi-center, open label study to collect and assess long-term safety of everolimus in patients being treated in current Novartis-sponsored studies and who were benefiting from treatment with everolimus judged by the investigator.There was no screening period for this study. Eligible patients were consented and started their treatment with everolimus as soon as they entered the study. Patients had to return to the study center on a yearly basis (± 3 months), but for resupply of study medication, the frequency of the receipt and dispensing followed local practice (e.g., every 2 to 3 months). The dose of everolimus was based on the investigator's judgment.

Adverse events (AEs) were collected continuously throughout the study. For the safe and effective use of everolimus, patient could return to the clinic at any given time following local practice. When AEs were observed, additional visits were arranged by investigator's discretion.

Patients continued to be treated until they were no longer benefiting from everolimus as defined in the parent protocol (disease progression), developed unacceptable toxicities, withdrew consent, were non-compliant to the protocol, the investigator felt it is no longer in the patient's best interest to continue everolimus therapy or the patient died, whichever came first.

A patient reached the end of study when everolimus treatment was permanently discontinued and the end of treatment visit had been performed. All patients were followed for AEs for 30 days after the last dose of everolimus.

The study remained open for approximately 5 years; until such time that enrolled patients no longer needed treatment with everolimus, whichever came first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their requirements in the parent study
Patient is currently benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.

Exclusion criteria

Patient has been permanently discontinued from everolimus study treatment in the parent study.

Treatment and study plan

Everolimus

Drug

Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.

Primary outcomes

Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability

Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 5 years.

Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Dec 23, 2013
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed