A Phase 4 interventional study of everolimus in Pancreatic Neuroendocrine Tumors, sponsored by Novartis Pharmaceuticals. Completed at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 61 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Everolimus is taken at a starting dose of 10 mg orally once daily.Patients will be provided with adequate supply of study treatment for self-administration at home until at least their next scheduled study visit.All patients will be followed for adverse events and serious adverse events for 30 days following the last dose of study drug. Beyond these 30 days, any serious adverse events that are suspected to be related to the study drug will also be collected
Drug: everolimus
Everolimus is taken at a starting dose of 10 mg orally once daily.Patients will be provided with adequate supply of study treatment for self-administration at home until at least their next scheduled study visit.All patients will be followed for adverse events and serious adverse events for 30 days following the last dose of study drug. Beyond these 30 days, any serious adverse events that are suspected to be related to the study drug will also be collected
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Incidences of AEs, AE suspected to be related to Afinitor, Grade 3/4 AEs and SAEs
Time frame: 5 years
Overall Survival
Overall Survival is defined as time from study treatment to death due to any cause
Time frame: Baseline, Week 4, every 3 months during treatment, every 6 months during survival through study completion which is defined as 75% completed survival (death) or ended treatment 5 years earlier (approximately 5 years)
Progression free survival
Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause
Time frame: Baseline, WK 4, every 3 MO during treatment until disease progression, unacceptable toxicity or discontinue treatment, every 6 MO during survival to study completion ( defined as 75% completed survival (death) or ended treatment 5 YRs earlier
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals