18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· 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
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 (Safety database)
Group
Value
95% CI
Everolimus
6
Everolimus+Sandostatin LAR
9
Treatment-related SAEs (Safety database)
Group
Value
95% CI
Everolimus
1
Everolimus+Sandostatin LAR
4
AEs (Clinical Database)
Group
Value
95% CI
Everolimus
7
Everolimus+Sandostatin LAR
7
Tretament-related AEs (Clinical Database)
Group
Value
95% CI
Everolimus
4
Everolimus+Sandostatin LAR
4
SAEs (Clinical Database)
Group
Value
95% CI
Everolimus
2
Everolimus+Sandostatin LAR
4
Treatment-related SAEs (Clinical Database)
Group
Value
95% CI
Everolimus
0
Everolimus+Sandostatin LAR
2
Percentage of Patients With Clinical BenefitSecondary· After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years
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.
At 3 months
Group
Value
95% CI
Everolimus
9
Everolimus+Sandostatin LAR
7
At 6 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 9 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 12 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 15 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 18 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 21 months
Group
Value
95% CI
Everolimus
8
Everolimus+Sandostatin LAR
7
At 24 months
Group
Value
95% CI
Everolimus
6
Everolimus+Sandostatin LAR
7
Adverse events — posted to ClinicalTrials.gov
Time frame: SAEs were collected in safety database from enrollment to end of the treatment (EOT) plus 30 days, up to approximately 7.2 years. Other AEs (Non-serious AEs) were collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
· EARLY_PHASE1
· recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
· Phase 1
· not yet recruiting
NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
· Phase 2
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06832189 — EVR and EPO for Liver Transplant Tolerance
· Phase 1
· recruiting
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 4
· not yet recruiting
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· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01789281.