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

Pancreatic Neuroendocrine Tumors Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842749
• Other study ID #: CRAD001PCN31
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2016
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Incidences of AEs, AE suspected to be related to Afinitor, Grade 3/4 AEs and SAEs	5 years
Secondary	Overall Survival	Overall Survival is defined as time from study treatment to death due to any cause	Baseline, Week 4, every 3 months during treatment, every 6 months during survival through study completion which is defined as 75% completed survival (death) or ended treatment 5 years earlier (approximately 5 years)
Secondary	Progression free survival	Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause	Baseline, WK 4, every 3 MO during treatment until disease progression, unacceptable toxicity or discontinue treatment, every 6 MO during survival to study completion ( defined as 75% completed survival (death) or ended treatment 5 YRs earlier