CompletedPhase 4

Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China

China61 participantsStarted 2016-03-14

Plain-language summary

To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.

Who can participate

Age range18 Years – 100 Years

SexALL

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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

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 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.

Trial details

NCT IDNCT02842749

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-22

Results submitted2025-01-21

View on ClinicalTrials.gov More Pancreatic Neuroendocrine Tumors trials