Phase 4
Completed N=34
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
Neoplasms
Source: ClinicalTrials.gov NCT01789281 ↗
Enrolled (actual)
34
Serious AEs
44.1%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 9; 1; 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 9; 1; 4; 7; 7 | — |
| SECONDARY Percentage of Patients With Clinical Benefit |
9; 7; 8; 7; 8; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01789281). 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.