drugset / Trial / NCT02017860

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.

NCT02017860 ↗

Phase 2 Completed 4 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01-16
Primary completion
2019-04-25
Completion
2019-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 2.5 mg Oral
Subject Everolimus Small molecule 5 mg Oral

Indications