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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02842749
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE March 14, 2016
Estimated Primary Completion Date December 2, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02842749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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 Measures  ICMJE
 (submitted: July 22, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
Official Title  ICMJE 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.
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neuroendocrine Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: everolimus (single arm)
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: Drug: everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2016)
20
Estimated Study Completion Date  ICMJE December 2, 2024
Estimated Primary Completion Date December 2, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842749
Other Study ID Numbers  ICMJE CRAD001PCN31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP