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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 )

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors Drug: everolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 14, 2016
Estimated Primary Completion Date : December 2, 2024
Estimated Study Completion Date : December 2, 2024


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842749


Locations
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China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Shanghai
Novartis Investigative Site
Shanghai, Shanghai, China, 200032
China
Novartis Investigative Site
Beijing, China, 100039
Novartis Investigative Site
Guangzhou, China, 510060
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02842749     History of Changes
Other Study ID Numbers: CRAD001PCN31
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents