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

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Everolimus; Drug: Sandostatin LAR Depot

Detailed Description

This multi-center, open-label roll-over study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a Novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the Investigator.

The study was designed to provide continued treatment with everolimus monotherapy to the subjects. Subjects were allowed to continue combination therapy with Sandostatin LAR® Depot if they were receiving this combination therapy on the parent protocol. Subjects were allowed to continue in this roll-over study until they no longer benefitted from the everolimus treatment as judged by the Investigator, discontinued due to toxicities, subject withdrew consent or lost to follow-up, disease progression, protocol non-compliance, or subject death, whichever occurred first. A subject was considered to have reached end of study when everolimus treatment was permanently discontinued.

As per the original protocol, it was designed to collect only serious adverse events (SAEs) and protocol defined adverse events of special interest (AESIs). However, due to the feedback received from health authorities, the protocol was amended in 2016 (3 years after study was initiated) to collect all AEs (non-serious and serious AEs, and AESIs). The protocol was also amended to include an Investigator assessment of clinical benefit at every visit for remaining subjects.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Praha 2, Czech Republic, Czechia, 120 00
      • Novartis Investigative Site
• Italy
  • AR
    • Arezzo, AR, Italy, 52100
      • Novartis Investigative Site
  • MI
    • Milano, MI, Italy, 20133
      • Novartis Investigative Site
    • Milano, MI, Italy, 20141
      • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Novartis Investigative Site
• Russian Federation
  • Russia
    • Leningrad Region, Russia, Russian Federation, 188663
      • Novartis Investigative Site
• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
      • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
• Turkey
  • Izmir, Turkey, 35040
    • Novartis Investigative Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Hematology Oncology Services of Arkansas SC
  • Colorado
    • Greenwood Village, Colorado, United States
      • Rocky Mountain Cancer Centers SC
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center and Research Institute SC-2
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Central Indiana Cancer Centers SC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Crescent City Research Consortium, LLC SC-3
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic SC-2
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine Dept of Oncology
  • Nebraska
    • Omaha, Nebraska, United States, 68154
      • Nebraska Cancer Specialists Onc Dept
  • New York
    • Lake Success, New York, United States, 11042
      • Clinical Research Alliance
    • New York, New York, United States, 10016
      • New York University Medical Center SC-4
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University SC-8
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists Utah Cancer (2)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the parent study
• Subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.

Exclusion Criteria:

• Subject was permanently discontinued from everolimus study treatment in the parent study.
• Subject was receiving everolimus in combination with an unapproved or experimental treatment

Other protocol-defined inclusion/exclusion criteria might apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Everolimus; Participants who were receiving everolimus in a Novartis-sponsored study, were not progressing on the current study treatment and were unable to access everolimus treatment outside of a clinical trial. Participants receiving everolimus treatment in combination with Sandostatin LAR Depot on the parent protocol were allowed to continue Sandostatin LAR Depot treatment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately.	SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Clinical Benefit	Percentage of patients with clinical benefit as judged by the investigator. Investigator attestation of continued clinical benefit was collected in clinical database after protocol amendment (release date 18 March 2016). Clinical benefit assessment before protocol amendment was done retrospectively.	After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2013
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Neoplasms; Neuroendocrine tumor; Carcinoid tumor
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide; Everolimus
• Other Study ID Numbers: CRAD001C2X01B; 2012-004707-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No