NCT02842749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 10, 2025

Completed
Last Updated

February 10, 2025

Status Verified

January 1, 2025

Enrollment Period

7.9 years

First QC Date

June 16, 2016

Results QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

Pancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with treatment emergent adverse events (any AE regardless of seriousness), SAEs, AEs and SAEs on grade 3 or 4, and suspected to be related to the study drug.

    Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period of 30 days, up to a maximum duration of approximately 5 years.

Secondary Outcomes (2)

  • Overall Survival (OS)

    Up to approximately 7 years and 6 months.

  • Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1

    Up to approximately 2 years and 9 months

Study Arms (1)

everolimus (single arm)

EXPERIMENTAL

Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.

Drug: everolimus

Interventions

everolimusDRUG

Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.

everolimus (single arm)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200032, China

Location

Novartis Investigative Site

Beijing, 100039, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
+ 1 862 778 8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 25, 2016

Study Start

March 14, 2016

Primary Completion

February 22, 2024

Study Completion

February 22, 2024

Last Updated

February 10, 2025

Results First Posted

February 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Locations

CN(5)