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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02017860
First received: December 17, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to collect and assess long-term safety of everolimus in patients who are currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol and are unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study will be decided by Novartis. Investigator initiated trials (IITs) will not be included. The primary objective of the parent study must have been reached and the parent study must be in the process of being completed and reported.


Condition Intervention Phase
Neoplasms
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multi-center Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study and Are Judged by the Investigator to Benefit From Continued Everolimus Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of pariticipants with Adverse events as a measure of safety and tolerability [ Time Frame: From screening period to the end of the study (approximately 6 years) ] [ Designated as safety issue: Yes ]
    Long term safety. Frequency and nature of Adverse Events are to be collected.


Estimated Enrollment: 2
Study Start Date: January 2014
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Patients who are receiving everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol and are unable to access everolimus treatment outside of a clinical trial will be allowed to enroll.
Drug: Everolimus
Everolimus will be provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient has been permanently discontinued from everolimus study treatment in the parent study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017860

Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

Locations
Japan
Novartis Investigative Site Recruiting
Matsuyama, Ehime, Japan, 791-0280
Novartis Investigative Site Recruiting
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site Withdrawn
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02017860     History of Changes
Other Study ID Numbers: CRAD001C1X01B
Study First Received: December 17, 2013
Last Updated: September 11, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
RAD001, everolimus, roll-over

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 01, 2014