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

NCT02305810 | Completed Phase 2

• 1 other identifier: S543/310
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neuroendocrine Tumour Metastatic

Outcome Measures

Primary Outcomes (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.

  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)

  Baseline, week 4, week 12 up to tumor progression

Secondary Outcomes (3)

• Overall survival (OS)

  Baseline to death

• RR (response rate) , including SD (stable disease) and PR (partial response)

  Baseline to best tumor response or unacceptable toxicity

• TTP, time to progression

  Baseline to tumor progression or unacceptable toxicity

Study Arms (1)

Single arm receiving everolimus

EXPERIMENTAL

single treatment arm receiving everolimus 10 mg daily

Drug: Everolimus 10 mg daily

Interventions

Everolimus 10 mg daily DRUG

everolimus is a recently approved mTOR inhibitor in advanced progressing well/moderately differentiated pancreatic neuroendocrine tumors

Also known as: RAD 001

Single arm receiving everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of metastatic well/moderately differentiated pancreatic neuroendocrine tumor

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Nicola Fazio, MD,PhD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: December 3, 2014
• Study Start: September 1, 2013
• Primary Completion: January 12, 2017
• Study Completion: June 1, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-09

Locations

IT (1)