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

• Status: Active, not recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

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