- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02017860
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.
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 Overview
Detailed Description
This was a multi-center, open label study to collect and assess long-term safety of everolimus in patients being treated in current Novartis-sponsored studies and who were benefiting from treatment with everolimus judged by the investigator.There was no screening period for this study. Eligible patients were consented and started their treatment with everolimus as soon as they entered the study. Patients had to return to the study center on a yearly basis (± 3 months), but for resupply of study medication, the frequency of the receipt and dispensing followed local practice (e.g., every 2 to 3 months). The dose of everolimus was based on the investigator's judgment.
Adverse events (AEs) were collected continuously throughout the study. For the safe and effective use of everolimus, patient could return to the clinic at any given time following local practice. When AEs were observed, additional visits were arranged by investigator's discretion.
Patients continued to be treated until they were no longer benefiting from everolimus as defined in the parent protocol (disease progression), developed unacceptable toxicities, withdrew consent, were non-compliant to the protocol, the investigator felt it is no longer in the patient's best interest to continue everolimus therapy or the patient died, whichever came first.
A patient reached the end of study when everolimus treatment was permanently discontinued and the end of treatment visit had been performed. All patients were followed for AEs for 30 days after the last dose of everolimus.
The study remained open for approximately 5 years; until such time that enrolled patients no longer needed treatment with everolimus, whichever came first.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- Novartis Investigative Site
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Hokkaido
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Sapporo city, Hokkaido, Japan, 060 8648
- Novartis Investigative Site
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Osaka
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Osaka-city, Osaka, Japan, 540-0006
- Novartis Investigative Site
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Saitama
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Kitaadachi-gun, Saitama, Japan, 362-0806
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Everolimus
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.
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Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 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.
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Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
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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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAD001C1X01B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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