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2016-03-14
2024-02-22
2024-02-22
61
NCT02842749
Novartis
Novartis
INTERVENTIONAL
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
This was an open-label, multicenter, single-arm clinical study to evaluate the safety and efficacy of everolimus in Chinese adult patients with locally advanced, unresectable or metastatic, well differentiated progressive pancreatic neuroendocrine tumors. The inclusion and exclusion criteria, as well as the dosing and dose modification criteria are designed according to the approved Chinese Package Insert. The planned sample size of the study was approximately 60 subjects. Subjects who were eligible received the treatment with everolimus provided by sponsor to treat pNET and followed the visit schedule in the protocol to collect safety and efficacy data until progression of disease, unacceptable toxicity, death, protocol deviation or other reason that may lead to discontinuation before the end of study. All subjects were followed-up for survival status every 6 months by the investigator until death, lost to follow-up, withdrawal of consent for survival or end of study. The Ȯnd of study" is defined as either at least 75% of subjects have completed survival follow up or all subjects discontinued study treatment or the last subject finished 5-year survival follow up, whichever comes first. Final analysis was conducted at the end of the study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-06-16 | 2025-01-21 | 2025-01-21 |
2016-07-22 | 2025-01-21 | 2025-02-10 |
2016-07-25 | 2025-02-10 | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: everolimus (single arm) Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment. | DRUG: everolimus
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent adverse events (any AE regardless of seriousness), SAEs, AEs and SAEs on grade 3 or 4, and suspected to be related to the study drug. | Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period of 30 days, up to a maximum duration of approximately 5 years. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival is defined as the time from the start of study treatment to death due to any cause. OS was analyzed using the Kaplan-Meier method. | Up to approximately 7 years and 6 months. |
| Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1 | Progression free survival is defined as the time from the initiation of study treatment to disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier estimates. | Up to approximately 2 years and 9 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
