Overview

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