Study Of Everolimus Treatment In Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

Study Overview

Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

The purpose of this study is to explore the efficacy and safety of everolimus administered as a first-line treatment in newly-diagnosed patients with advanced or inoperable Gastrointestinal (GI) or pancreatic neuroendocrine tumors.

N/A

Gastrointestinal Tumors
Pancreatic Tumors
Gastrointestinal Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors

DRUG: Everolimus

HE 67/12
2011-006160-48 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-07-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-08-30
First Submitted that Met QC Criteria 2012-07-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-03
First Posted (ACTUAL) 2012-07-24	Results First Posted N/A	Last Verified 2019-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Everolimus	DRUG: Everolimus Everolimus 10mg(2x5mg)orally once daily until disease progression, unacceptable toxicity or consent withdrawal

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Everolimus

DRUG: Everolimus

Everolimus 10mg(2x5mg)orally once daily until disease progression, unacceptable toxicity or consent withdrawal

Primary Outcome Measures	Measure Description	Time Frame
15 month PFS (Progression-Free Survival) rate	To determine the rate of PFS patients at 15 months of treatment.	15 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression-Free Survival (PFS)		Defined as the time from the date of enrollment to the date of 1st radiologically documented disease progression or disease related death,assessed up to 36 months.
Overall Survival (OS)		Defined as the time from the date of enrollment to the date of death from any cause,assessed up to 36 months.
Evaluation of best response to treatment and the time to best response achievement		Defined as the period from the date of treatment initiation to best response observation date througout the study, assessed up to 15 months.
Assessment of safety		Assessment of adverse events will be performed every 28 days (per cycle) during treatment, assessed up to 16 months.
Association of biologic markers with disease progression		Up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

unstable angina pectoris, symptomatic congestive heart failure NYHA class II, III, IV, myocardial infarction ≤ 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia (LVEF < 50 %)
active or uncontrolled severe infection
cirrhosis, chronic active hepatitis, chronic persistent hepatitis or inadequate hepatic function (ALT/SGPT and AST/SGOT > 5 x ULN)
inadequate bone marrow (ANC < 1.5 x 10^9/L, platelets < 100 x 10^9/L, hemoglobin ≤ 9 g/dL) or renal failure (serum creatinine > 1.5 x ULN
severely impaired lung function (patients needing oxygen support). 8. Active bleeding diathesis or on oral treatment with vitamin K antagonists (apart from low-dose coumadine). 9. Performance status ≥ 3 on the WHO scale. 10. Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required. 11. No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or treated in situ cancer of the cervix, or any other cancer from which the patient has been disease free for ≥ 3 years. 12. Patients within 28 days post-major surgery (e.g. intra-thoracic, intrabdominal or intra-pelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry. Note: Patients must have recovered from the acute effects of surgery prior to enrollment. 13. Female patients who are pregnant or nursing (lactating). 14. Adults with reproductive potential who are not using effective birth control methods. If barrier contraceptive measures are being used, these must be continued throughout the study by both sexes. 15. Patients participating in another clinical trial or receiving an investigational drug. 16. Patients unwilling or unable to comply with the protocol at the investigator's discretion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Novartis

Investigators

STUDY_CHAIR: Anna Koumarianou, Dr, 4th Dept of Internal Medicine, University Hospital Ȫttikon"

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Koumarianou A, Pectasides D, Koliou GA, Dionysopoulos D, Kolomodi D, Poulios C, Skondra M, Sgouros J, Pentheroudakis G, Kaltsas G, Fountzilas G. Efficacy and Safety of First-Line Everolimus Therapy Alone or in Combination with Octreotide in Gastroenteropancreatic Neuroendocrine Tumors. A Hellenic Cooperative Oncology Group (HeCOG) Study. Biology (Basel). 2020 Mar 9;9(3):51. doi: 10.3390/biology9030051.

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