Clinical trialPhase 4Completed
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
Phase IV, Open-label, Multi-center, Single-arm Study of the Safety and Efficacy of Everolimus (Afinitor) in Adult Patients With Locally Advanced, Unresectable or Metastatic, Well Differentiated Progressive Pancreatic Neuroendocrine Tumors (pNET) in China.
- Outcome
- Outcome unknown
- Phase
- Phase 4
- Status
- Completed
- Study type
- Interventional
- Start
- 14 March 2016
- Expected end
- 22 February 2024
- Enrollment
- 61 participants
- Sites
- 5
- Primary outcomes
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Sponsor
- Industry
- Results posted
- 2025-02-10
- Last update
- 10 February 2025
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
Detailed description public domain (ClinicalTrials.gov)
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 "End 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [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.]. Count Of Participants, Participants. AEs: Everolimus (n=61): 60. AEs-grade 3/4: Everolimus (n=61): 30. AEs Suspected to be related to the study drug: Everolimus (n=61): 58. AEs Suspected to be related to the study drug-grade 3/4: Everolimus (n=61): 19. SAEs: Everolimus (n=61): 17. SAEs-grade 3/4: Everolimus (n=61): 11. SAEs Suspected to be related to the study drug: Everolimus (n=61): 8. SAEs Suspected to be related to the study drug-grade 3/4: Everolimus (n=61): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to approximately 7 years and 6 months.]. Median, months (95% Confidence Interval). Everolimus (n=61): 66.56 (39.66 to NA) [Not estimable due to insufficient number of participants with events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1 [Up to approximately 2 years and 9 months]. Median, months (95% Confidence Interval). Everolimus (n=61): 16.07 (11.04 to 21.52).