Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.

NCT01789281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-06-11

Study results available
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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

Conditions

  • Neoplasms

Interventions

DRUG

Everolimus

Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.

DRUG

Sandostatin LAR Depot

Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-14
Primary Completion
2020-08-28
Completion
2020-08-28
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Italy
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789281 on ClinicalTrials.gov