ClinicalTrials.gov
ClinicalTrials.gov Menu

A Biological Prospective Study in Patients With Metastatic Pancreatic NETs Treated With Everolimus

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: NCT02305810
Recruitment Status : Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Brief Summary:
Everolimus represents an approved therapy for patients with advanced well/moderately differentiated pancreatic NETs. Although some patients could benefit from this drug in terms of long-term tumor growth control, others are resistant upfront or become resistant during treatment. Therefore, it is crucial to detect some biological factors which can help to identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism of action can be partially directed towards angiogenesis its effects can be studied on different levels and with different methods. Upfront and early surrogate predictive markers of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood. mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic factors will be correlated with clinical outcome. Tumor perfusion and circulating markers will be studied also as markers of response compared with the morphological imaging.

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumour Metastatic Drug: Everolimus 10 mg daily Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Angiogenic Study in Patients With Well/Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors Treated With Everolimus
Study Start Date : September 2013
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Single arm receiving everolimus
single treatment arm receiving everolimus 10 mg daily
Drug: Everolimus 10 mg daily
everolimus is a recently approved mTOR inhibitor in advanced progressing well/moderately differentiated pancreatic neuroendocrine tumors
Other Name: RAD 001




Primary Outcome Measures :
  1. Circulating angiogenic factors, molecular imaging and tumor tissue factors changes during treatment with RAD001 at baseline, week 4, week 12 and at disease progression. [ Time Frame: Baseline, week 4, week 12 up to tumor progression ]
    Angiogenic factors (circulating endothelial cells, CECs; serum VEGF, bFGF, VEGFR-2, TSP-1) determined by serum samples; tumor tissue mTOR pathway alterations determined by Immunohistochemical staining ; ADC (apparent diffusion coefficient) calculated by Magnetic Resonance Imaging (MRI)


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Baseline to death ]
    Survival status

  2. RR (response rate) , including SD (stable disease) and PR (partial response) [ Time Frame: Baseline to best tumor response or unacceptable toxicity ]
    Clinical and/or radiological response

  3. TTP, time to progression [ Time Frame: Baseline to tumor progression or unacceptable toxicity ]
    Time from baseline to clionical/radiological signs of disease progression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Histological diagnosis of metastatic well/moderately differentiated pancreatic neuroendocrine tumor
  2. Patient incoming to be treated with everolimus outside clinical trials or within a clinical trial that permits the concurrent inclusion in an ancillary trial
  3. Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion Criteria:

  1. Patients with poorly differentiated neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, small cell carcinoma, Merkel cell carcinoma.
  2. Patients with pancreatic NETs not eligible to be treated with everolimus
  3. Patients with ongoing everolimus treatment
  4. Prior therapy with mTOR inhibitors

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): NCT02305810


Locations
Italy
European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Nicola Fazio, MD,PhD European Institute of Oncology

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT02305810     History of Changes
Other Study ID Numbers: S543/310
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents