Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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17 August 2021 |
Main ID: |
EUCTR2011-002887-26-IT |
Date of registration:
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06/03/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study of everolimus plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced neuroendocrine cancer of gastrointestinal or lung origin
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Scientific title:
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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 - RADIANT-4 |
Date of first enrolment:
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14/03/2012 |
Target sample size:
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279 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002887-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Canada
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China
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Colombia
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Czech Republic
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Germany
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Greece
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Hungary
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Italy
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Japan
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Korea, Republic of
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Lebanon
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Netherlands
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Norway
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Peru
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Poland
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Russian Federation
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Saudi Arabia
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Slovakia
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South Africa
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Spain
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Taiwan
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Drug Regulatory Affairs
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Address:
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Largo Umberto Boccioni, 1
21040
ORIGGIO
Italy |
Telephone:
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+39 02 96541 |
Email:
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info.studiclinici@novartis.com |
Affiliation:
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NOVARTIS FARMA |
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Name:
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Drug Regulatory Affairs
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Address:
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Largo Umberto Boccioni, 1
21040
ORIGGIO
Italy |
Telephone:
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+39 02 96541 |
Email:
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info.studiclinici@novartis.com |
Affiliation:
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NOVARTIS FARMA |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin. 2.No history of and no active symptoms related to carcinoid syndrome (or other hypersecretory syndromes). 3.Patients treated with prior SSA and/or Interferon (IFN) may be included. These patients must discontinue treatment prior to the day of randomization as follows: 4.Radiological documented disease progression within 3 months prior to randomization 5.Measurable disease 6.WHO performance status =2 7.Adequate bone marrow, lifer and renal function Other protocol-defined inclusion/exclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 93 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 184
Exclusion criteria: 1.Patients with poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, gastrinoma, goblet cell carcinoid, and small cell carcinoma. 2.Patients with NET of pancreatic origin. 3.Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea). 4.Prior systemic cytotoxic chemotherapy or targeted therapy. 6.Hepatic intra-arterial embolization within the last 6 months (or 1 month if there is measurable disease in other organs besides the liver) 7.Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus). 8.Known intolerance or hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus). 9.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus. 10.Uncontrolled diabetes mellitus. 11.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). 12.Chronic treatment with corticosteroids or other immunosuppressive agents. 13.Known history of HIV seropositivity. 14.Pregnant or nursing (lactating) women. Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced neuroendocrine tumor (NET) of GI or lung origin MedDRA version: 14.1
Level: PT
Classification code 10052399
Term: Neuroendocrine tumour
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: AFINITOR*30CPR 5MG Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To compare overall survival (OS) between study arms. To determine the safety and tolerability of everolimus in this patient population.
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Primary end point(s): Progression free survival (PFS)
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Main Objective: Determinate whether treatment with everolimus plus best supportive care prolongs PFS compared to placebo plus best supportive care in patients with advanced NET of GI or lung origin
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Timepoint(s) of evaluation of this end point: Every 12 weeks until disease progression, start of futher anti-tumor therapy or intolerable toxicity, whichever comes first.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. Continuously during the treatment period. Every 12 weeks during follow-up. 2. Continuously 3. Every 12 weeks until start of futher anti-tumor therapy. 4. Every 12 weeks until disease progression, start of futher anti-tumor therapy or intolerable toxicity, whichever comes first. 5. Every visit until end of treatment.
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Secondary end point(s): 1. Overall Survival (OS). 2. Safety evaluation and efficacy in everolimus. 3. FACT-G total score over time. 4. Objective response rate (ORR). 5. Changes from baseline in Chromogranin A (CgA) and Neuron specific enolase (NSE) levels.
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Secondary ID(s)
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2011-002887-26-BE
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CRAD001T2302
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date: 21/02/2012
Contact:
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