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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


Phase 4
N/A
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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.

- Patient is receiving everolimus in combination with an unapproved or experimental
treatment

- Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients receiving everolimus

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2X01B

NCT ID:

NCT01789281

Start Date:

March 2013

Completion Date:

June 2022

Related Keywords:

  • Neoplasms
  • Neoplasms, Carcinoid tumor, Neuroendocrine tumor
  • Neoplasms

Name

Location

Stamford HospitalStamford, Connecticut  06904
US Oncology Central MonitoringDallas, Texas  75246
Hematology Oncology Services of Arkansas SCLittle Rock, Arkansas  72205
Rocky Mountain Cancer Centers SCGreenwood Village, Colorado  
Central Indiana Cancer Centers SCIndianapolis, Indiana  46227
Washington University School Of Medicine-Siteman Cancer Ctr Dept of OncologySt. Louis, Missouri  63110
Virginia Oncology Associates SCNorfolk, Virginia  23502