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 Local Advanced or Metastatic, Well Differentiated Progressive Pancreatic Neuroendocrine Tumors (pNET) in China.

ClinicalTrials.gov Identifier: NCT02842749

Novartis Reference Number: CRAD001PCN31

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Pancreatic Neuroendocrine Tumors
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
49 participants
Start date 
Mar 14, 2016
Completion date 
Dec 02, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
everolimus
Everolimus is taken at a starting dose of 10 mg orally once daily.Patients will be provided with adequate supply of study treatment for self-administration at home until at least their next scheduled study visit.All patients will be followed for adverse events and serious adverse events for 30 days following the last dose of study drug. Beyond these 30 days, any serious adverse events that are suspected to be related to the study drug will also be collected

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

Study Locations

China
Novartis Investigative Site
-
Beijing, 100730
Beijing
China
Novartis Investigative Site
-
Shanghai, 200032
Shanghai
China
Novartis Investigative Site
-
Beijing, 100039
-
China
Novartis Investigative Site
-
Guangzhou, 510060
-
China

Have a question?

Call 1-999-669-6682 or email [email protected]