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 | Completed Phase 2 Results

• 1 other identifier: CRAD001C1X01B
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Neoplasms

Keywords

RAD001, everolimus, roll-over

Outcome Measures

Primary Outcomes (1)

• Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability

  Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

  Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 5 years.

Study Arms (1)

Everolimus

EXPERIMENTAL

Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (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 trial were enrolled.

Drug: Everolimus

Interventions

Everolimus DRUG

Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient has been permanently discontinued from everolimus study treatment in the parent study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Matsuyama, Ehime, 791-0280, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 540-0006, Japan

Location

Novartis Investigative Site

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: January 16, 2014
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (4)