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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01789281
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Everolimus Drug: Sandostatin LAR Depot Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 14, 2013
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : August 28, 2020


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.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Patients With Clinical Benefit [ Time Frame: After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789281


Locations
Show Show 24 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] March 18, 2016
Statistical Analysis Plan  [PDF] June 9, 2020

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01789281    
Other Study ID Numbers: CRAD001C2X01B
2012-004707-12 ( EudraCT Number )
First Posted: February 12, 2013    Key Record Dates
Results First Posted: June 11, 2021
Last Update Posted: June 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Neoplasms
Carcinoid tumor
Neuroendocrine tumor
Additional relevant MeSH terms:
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Neoplasms
Everolimus
Octreotide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal