Back to resultsPhase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
Primary Purpose
Pancreatic Neuroendocrine Tumors
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neuroendocrine Tumors
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
everolimus (single arm)
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall Survival
Overall Survival is defined as time from study treatment to death due to any cause
Progression free survival
Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02842749
Brief Title
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2016 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neuroendocrine Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
everolimus (single arm)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Incidences of AEs, AE suspected to be related to Afinitor, Grade 3/4 AEs and SAEs
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival is defined as time from study treatment to death due to any cause
Time Frame
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)
Title
Progression free survival
Description
Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
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