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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 years ]

Incidences of AEs, AE suspected to be related to Afinitor, Grade 3/4 AEs and SAEs


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival [ 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) ]
    Overall Survival is defined as time from study treatment to death due to any cause
  • Progression free survival [ 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 ]
    Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause


Original Secondary Outcome:

  • Overall Survival [ Time Frame: through study completion estimated to be approximately 5 years ]
    Overall Survival is defined as time from study treatment to death due to any cause
  • Progression free survival [ Time Frame: Baseline, Week 4, every 3 Month during treatment until disease progression, unacceptable toxicity or discontinue treatment, every 6 Month during survival to study completion ( defined as 75% completed survival (death) or ended treatment 5 Years earlier ]
    Progression free survival is defined as time from first dose of study treatment to progression or death due to any cause


Information By: Novartis

Dates:
Date Received: June 16, 2016
Date Started: March 14, 2016
Date Completion: September 4, 2023
Last Updated: May 12, 2017
Last Verified: May 2017