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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor (RADIANT-2)

Primary Purpose

Carcinoid Tumor, Malignant Carcinoid Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Octreotide
Placebo
Everolimus
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Tumor focused on measuring Cancer, Carcinoid, Tumor, Neuroendocrine, Carcinoma, Everolimus, Octreotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Advanced (unresectable or metastatic) carcinoid tumor
  • Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
  • Documented progression of disease within 12 months prior to randomization.
  • Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion criteria:

  • Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
  • Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
  • Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
  • Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
  • Severe or uncontrolled medical conditions
  • Chronic treatment with corticosteroids or other immunosuppressive agent.
  • Other primary cancer within 3 years.

Other protocol-defined inclusion/exclusion criteria applied

Sites / Locations

  • University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
  • Highlands Oncology Group The Center for Chest Care
  • Hematology Oncology Services of Arkansas
  • Pacific Cancer Medical Center, Inc.
  • Cedars Sinai Medical Center SC-2
  • University of California at Los Angeles UCLA New SC Address
  • University of Colorado Dept. of Univ. of Colorado
  • Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
  • Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
  • Cancer Centers of Connecticut Southington Location
  • Hematology Oncology PC Dept.of Hematology Oncology(2)
  • Ocala Oncology Center Dept. of Ocala Oncology Center
  • Cancer Care and Hematology Specialists of Chicagoland Niles
  • Indiana University Dept.of IndianaUniv.CancerCtr
  • Central Indiana Cancer Centers CICC - South
  • University of Iowa Medical Center Internal Medicine
  • University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
  • Kansas City Cancer Center KCCC Business Office
  • Norton Cancer Institute Clinical Research Program
  • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
  • Mayo Clinic - Rochester Division of Hematology
  • Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology
  • The Center for Cancer Care and Research
  • Dartmouth Hitchcock Medical Center Medical Oncology
  • New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
  • New York University Medical Center NYU Medical Center (2)
  • Duke University Medical Center Dept. of Duke Cancer Center
  • Fox Chase Cancer Center
  • Cancer Centers of the Carolinas CC of C -Eastside
  • Texas Oncology, P.A. Central Austin Cancer Center
  • South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
  • Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
  • Texas Oncology, P.A. Forth Worth -- 12th Avenue
  • University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
  • Tyler Cancer Center
  • Virginia Oncology Associates VOA - Lake Wright
  • Northwest Cancer Specialists Compass Oncology -BKM
  • University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Octreotide+ Everolimus

Octreotide+ Placebo

Arm Description

Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.

Secondary Outcome Measures

Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)
The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
Overall Survival Using Kaplan-Meier Methodology
Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".

Full Information

First Posted
December 13, 2006
Last Updated
November 11, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00412061
Brief Title
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
Acronym
RADIANT-2
Official Title
A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Tumor, Malignant Carcinoid Syndrome
Keywords
Cancer, Carcinoid, Tumor, Neuroendocrine, Carcinoma, Everolimus, Octreotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Octreotide+ Everolimus
Arm Type
Experimental
Arm Description
Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Arm Title
Octreotide+ Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Sandostatin LAR® Depot
Intervention Description
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
RAD001
Intervention Description
A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
Description
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
Time Frame
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Secondary Outcome Measure Information:
Title
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Description
The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Time Frame
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Title
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
Description
5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
Time Frame
If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Title
Overall Survival Using Kaplan-Meier Methodology
Description
Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
Time Frame
Months 12, 24, 36, 48
Title
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
Description
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame
From first day of treatment up to 28 days after last day of treatment in double blind
Title
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
Description
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame
From first day of treatment up to 28 days after last day of treatment in double blind
Title
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
Description
Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".
Time Frame
If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Advanced (unresectable or metastatic) carcinoid tumor Confirmed low-grade or intermediate-grade neuroendocrine carcinoma Documented progression of disease within 12 months prior to randomization. Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI). Exclusion criteria: Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma. Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment. Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus) Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins. Severe or uncontrolled medical conditions Chronic treatment with corticosteroids or other immunosuppressive agent. Other primary cancer within 3 years. Other protocol-defined inclusion/exclusion criteria applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Highlands Oncology Group The Center for Chest Care
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Hematology Oncology Services of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Cedars Sinai Medical Center SC-2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California at Los Angeles UCLA New SC Address
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado Dept. of Univ. of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Cancer Centers of Connecticut Southington Location
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Hematology Oncology PC Dept.of Hematology Oncology(2)
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Ocala Oncology Center Dept. of Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Indiana University Dept.of IndianaUniv.CancerCtr
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Central Indiana Cancer Centers CICC - South
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
University of Iowa Medical Center Internal Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas City Cancer Center KCCC Business Office
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Norton Cancer Institute Clinical Research Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mayo Clinic - Rochester Division of Hematology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Center for Cancer Care and Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center Medical Oncology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York University Medical Center NYU Medical Center (2)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center Dept. of Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Cancer Centers of the Carolinas CC of C -Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Texas Oncology, P.A. Central Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78405
Country
United States
Facility Name
Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology, P.A. Forth Worth -- 12th Avenue
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates VOA - Lake Wright
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Cancer Specialists Compass Oncology -BKM
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Novartis Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Novartis Investigative Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Pribram
ZIP/Postal Code
261 95
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
FIN-00290
Country
Finland
Facility Name
Novartis Investigative Site
City
Clichy Cédex
ZIP/Postal Code
92118
Country
France
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
GR 11527
Country
Greece
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06132
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28444114
Citation
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PubMed Identifier
23187897
Citation
Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.
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PubMed Identifier
22119496
Citation
Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com
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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

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