Phase 2 Completed N=4 Treatment

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.

Source: ClinicalTrials.gov NCT02017860 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Apr 2020

Primary outcomePrimary: Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability — 4; 2 Count of Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability	4; 2	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02017860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.