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Trial details
RADIANT 4 - Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
Current status:
Approved
|
Date registered:
23/08/2021
Trial version(s)
History: 02/01/2020
History: 02/01/2020
Current: 02/01/2020
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Main Information
Primary registry identifying number
LBCTR2020011379
Protocol number
CRAD001T2302
MOH registration number
262/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This study was submitted prior to LBCTR initiation
Date of registration in national regulatory agency
13/01/2015
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
RADIANT 4 - Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
Acronym
Scientific title
A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin
Acronym
Brief summary of the study: English
The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with advanced nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.
Brief summary of the study: Arabic
دراسة عشوائية ومتعددة المراكز في المرحلة الثالثة لدواءEverolimusإيفيروليموس (RAD001)بالإضافة إلى أفضل عناية داعمة مقابل العلاج الإرضائي وأفضل عناية داعمة في علاج المرضى المصابين بحالة متقدمة من أورام الغدد الصمّ العصبية يكون مصدرها معديًا معويًا أو رئويًا - (RADIANT-4)مشع-4
Health conditions/problem studied: Specify
Advanced Nonfunctional NeuroEndocrine Tumor
Interventions: Specify
•Drug: Everolimus After randomization, patients will receive everolimus once daily until disease progression, intolerable toxicity, or consent withdrawal Other Name: RAD001 •Drug: Everolimus Placebo After randomization, patients will receive everolimus placebo once daily until disease progression, intolerable toxicity, or consent withdrawal
Key inclusion and exclusion criteria: Inclusion criteria
•Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin •No history of and no active symptoms related to carcinoid syndrome •In addition to treatment-naive patients, patients previously treated with SSA, Interferon (IFN), one prior line of chemotherapy, and/or PRRT are allowed into the study. Pretreated patients must have progressed on or after the last treatment •Radiological documented disease progression within 6 months prior to randomization •Measurable disease •WHO performance status ≤1 •Adequate bone marrow, liver and renal function
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
•Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma •Patients with pancreatic NET or NET of origins other than GI or Lung •Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea) •Patients with more than one line of prior chemotherapy •Prior targeted therapy •Hepatic locoregional therapy within the last 6 months •Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus) •Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus) •Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus •Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy •Patients who have any severe and/or uncontrolled medical conditions such as: ◦unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia ◦active or uncontrolled severe infection ◦liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) •Chronic treatment with corticosteroids or other immunosuppressive agents •Known history of HIV seropositivity •Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Austria, Belgium, Canada, China, Colombia, Czechia, Germany, ...
Name of IMP
everolimus (RAD001)
Year of authorization
2010
Month of authorization
5
Type of IMP
Cell therapy
Pharmaceutical class
proliferation signal inhibitor in the mammalian target of rapamycin (mTOR)
Therapeutic indication
proliferation signal inhibitor in the mammalian target of rapamycin (mTOR)
Therapeutic benefit
Progression Free Survival (PFS)
Biospecimen retention
Samples without DNA
Biospecimen description
Samples are sent to central quintiles laboratories
Target sample size
5
Actual enrollment target size
5
Date of first enrollment: Type
Actual
Date of first enrollment: Date
25/09/2012
Date of study closure: Type
Actual
Date of study closure: Date
04/06/2021
Recruitment status
Complete
Date of completion
17/07/2013
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT01524783
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical trials.gov
NCT01524783
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Shamseddin
Beirut
Lebanon
03344277
as04@aub.edu.lb
American University of beirut Medical Center
Scientific
Hind
Khairallah
Sin elfil
Lebanon
01512002#271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Joseph
Kattan
Beirut
Lebanon
011424942
jkattan62@hotmail.com
Hotel Dieu De France
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut Medical Center
Ali Shamseddin
Hematology
Approved
Hotel Dieu De France
Joseph Kattan
Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
11/03/2013
Fuad Ziyadeh
fz05@aub.edu.lb
961 (0) 1 350 000 ext:5445
Hotel Dieu de France
07/05/2012
Nancy Alam
nancy.alam@usj.edu.lb
961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Lebanon
Australia
Belgium
Canada
China
Colombia
Greece
Italy
Norway
Saudi Arabia
Turkey
United Arab Emirates
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Neuroendocrine tumor
Endocrine gland, unspecified (C75.9)
Neuroendocrine tumor
Interventions
Intervention
Description
Keyword
ICF, Lab tests , physical exam, radiology
ICF, Lab tests , physical exam, radiology
ICF, Lab tests , physical exam, radiology
Primary Outcomes
Name
Time points
Measure
Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier
18 months
18 months
Key Secondary Outcomes
Name
Time points
Measure
•Overall Survival (OS) Using Kaplan-Meier
18 Months
18 Months
•Overall Safety Evaluation of Everolimus Versus Placebo
5 years
5 years
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
CSR Synopsis- study close out
30/07/2021
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