Phase 4
Completed N=61
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
Source: ClinicalTrials.gov NCT02842749 ↗Enrolled (actual)
61
Serious AEs
27.9%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 60; 30; 58; 19 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
60; 30; 58; 19; 17; 11 | — |
| SECONDARY Overall Survival (OS) |
66.56 | — |
| SECONDARY Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1 |
16.07 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histological confirmed G1 or G2 pancreatic neuroendocrine tumors(pNETs) (WHO 2010)
- Patients must have radiological documentation of progression of disease per RECIST 1.1 within 12 months prior to enrollment.
- Measurable disease per RECIST 1.1 criteria using triphasic computed tomography (CT) scan or multiphase MRI for radiologic assessment.
- everolimus treatment which is recommended by the treating physician
Exclusion Criteria
- Hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
- Patient who is unwilling to receive Afinitor treatment due to any reason.
- Pregnant or nursing (lactating) women,
- Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
- Use of an investigational drug within the 30 days prior to enrollment
Data sourced from ClinicalTrials.gov (NCT02842749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.