A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DCC-2618
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years of age at the time of informed consent.
- Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
- Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
- Patients must have progressed on imatinib or have documented intolerance to imatinib.
- Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
- Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
- Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
- Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
- The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational studies) is permitted.
Exclusion Criteria:
- Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed.
- Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
- Patient has known active central nervous system metastases.
- New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
- Left ventricular ejection fraction (LVEF) < 50% at screening.
- Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
- Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
- 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QTc syndrome
- Use of known substrates or inhibitors of BCRP transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
- Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
- Any other clinically significant comorbidities.
- Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication
- malabsorption syndromes
- requirement for intravenous (IV) alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding.
Sites / Locations
- Mayo Clinic Scottsdale
- University of California San Diego Medical Center
- UCLA Hematology Oncology Center - Main Site
- Stanford Medicine
- University of Colorado Hospital - Anschutz Cancer Pavillion
- Rocky Mountain Cancer Centers
- Smilow Cancer Hospital at Yale
- Washington Cancer Institute at MedStar Washington Hospital Center
- Mayo Clinic Florida
- Sylvester Comprehensive Cancer Center
- Miami Cancer Institute at Baptist Health, Inc.
- Orlando Health UF Health Cancer Center
- Moffitt Cancer Center
- Winship Cancer Institute
- Georgia Cancer Specialists
- Northwestern Memorial Hospital
- University of Chicago Medical Center
- IU Simon Cancer Center
- University of Iowa Hospital and Clinics
- Norton Cancer Institute, Audubon Hospital Campus
- Johns Hopkins Hospital
- Dana Farber Cancer Institute
- Henry Ford Health System
- University of Minnesota Medical Center-Fairview
- Mayo Clinic
- Washington University School of Medicine - Siteman Cancer Center
- Rutgers Cancer Institute
- Montefiore Medical Center-Montefiore Medical Park
- Roswell Park Cancer Institute
- The Monter Cancer Center
- Memorial Sloan Kettering Cancer Center
- Duke University Medical Center
- The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute
- University of Toledo
- Stephenson Cancer Center
- Oregon Health & Science University Center for Health and Healing
- Fox Chase Cancer Center
- Henry-Joyce Cancer Clinic
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- University of Texas MD Anderson Cancer Center
- Virginia Commonwealth University Massey Cancer Center
- University of Washington Medical Center
- Froedtert Hospital-Medical College of Wisconsin
- Sanatorio Allende
- Instituto Medicao Especializado Alexander Fleming
- Border Medical Oncology Research Unit
- Prince of Wales Hospital
- Princess Alexandra Hospital
- Ashford Cancer Centre Research
- Ashford Cancer Centre Research
- The Alfred Hospital
- Princess Alexandara Hospital
- Institut Jules Bordet
- UZ Leuven
- Cross Cancer Institute
- CancerCare Manitoba
- Juravinski Cancer Centre
- The Ottawa Hospital Cancer Centre
- Princess Margaret Cancer Centre
- Hopital Maisonneuve-Rosemont
- Clinica San Carlos de Apoquindo Red Salud UC Christs
- Fakultni nemocnice v Motole
- Institut Bergonnié
- Centre Georges François Leclerc
- Centre Oscar Lambret
- Centre Léon Bérard
- Hopital La Timone
- IPC
- IGR
- CHU Poitiers-Hopital la Miletrie
- ICO - Site René Gauducheau
- HELIOS Klinikum Berlin-Buch
- Technische Universitat Dresden
- West German Cancer Center
- Magyar Honvedseg Egeszsegugyi Kozpont
- Debreceni Egyetem
- Shamir Medical Center (Assaf Harofeh)
- Rabin Medical Cente
- Tel-Aviv Sourasky Medical Center
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
- stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
- Fondazione IRCCS Istituto Nazionale dei Tumori
- IOV - Istituto Oncologico Veneto IRCCS
- Universita degli Studi di Palermo
- Università Campus Bio-Medico di Roma
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- Ajou University Hospital
- Antoni van Leeuwenhoek
- The Netherlands Cancer Institute
- University Medical Center Groningen
- Leiden University Medical Centre
- Oslo University Hospital
- Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
- National Cancer Centre
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital de Basurto
- Hospital Universitario 12 de Octubre
- Hospital Universitario Clinico San Carlos
- Hospital Universitario HM Madrid Sanchinarro
- Hospital Universitario La Paz
- Hospital Universitario Ramon y Cajal
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario Virgen del Rocio
- Instituto Valenciano de Oncología,
- Complejo Hospitalario Universitario de Vigo
- Karolinska universitetssjukhuset
- Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi
- Universitaetsspital Zuerich, Klinik fuer Onkologie
- Chang Gung Memorial Hospital
- Kaohsiung Chang Gung Memorial Hospital,
- China Medical University Hospital
- National Chen Kung University Hospital
- Taipei Veterans General Hospital
- Beatson West of Scotland Cancer Centre
- St James's University Hospital
- Royal Marsden Hospital - Fulham
- University College London Hospitals
- Weston Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DCC-2618
sunitinib
Arm Description
150 mg QD DCC-2618
50 mg QD sunitinib
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
PFS Based on independent radiologic review using modified RECIST
Secondary Outcome Measures
Objective response rate (ORR)
Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review
Overall Survival (OS)
Measure of overall survival
Full Information
NCT ID
NCT03673501
First Posted
September 13, 2018
Last Updated
January 4, 2021
Sponsor
Deciphera Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT03673501
Brief Title
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Acronym
intrigue
Official Title
A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deciphera Pharmaceuticals LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCC-2618
Arm Type
Experimental
Arm Description
150 mg QD DCC-2618
Arm Title
sunitinib
Arm Type
Active Comparator
Arm Description
50 mg QD sunitinib
Intervention Type
Drug
Intervention Name(s)
DCC-2618
Other Intervention Name(s)
ripretinib
Intervention Description
Oral KIT/PDGFRA kinase inhibitor
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
Oral receptor tyrosine kinase (RTK) inhibitor
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS Based on independent radiologic review using modified RECIST
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review
Time Frame
30 months
Title
Overall Survival (OS)
Description
Measure of overall survival
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥ 18 years of age at the time of informed consent.
Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
Patients must have progressed on imatinib or have documented intolerance to imatinib.
Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational studies) is permitted.
Exclusion Criteria:
Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed.
Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
Patient has known active central nervous system metastases.
New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Left ventricular ejection fraction (LVEF) < 50% at screening.
Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QTc syndrome
Use of known substrates or inhibitors of BCRP transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
Any other clinically significant comorbidities.
Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
If female, the patient is pregnant or lactating.
Known allergy or hypersensitivity to any component of the study drug.
Gastrointestinal abnormalities including but not limited to:
inability to take oral medication
malabsorption syndromes
requirement for intravenous (IV) alimentation
Any active bleeding excluding hemorrhoidal or gum bleeding.
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCLA Hematology Oncology Center - Main Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Stanford Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavillion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Smilow Cancer Hospital at Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Health UF Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Facility Name
Georgia Cancer Specialists
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
IU Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Cancer Institute, Audubon Hospital Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota Medical Center-Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine - Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers Cancer Institute
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center-Montefiore Medical Park
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
43606
Country
United States
Facility Name
The Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University Center for Health and Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert Hospital-Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sanatorio Allende
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Instituto Medicao Especializado Alexander Fleming
City
Buenos Aires
Country
Argentina
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Princess Alexandara Hospital
City
Woolloongabba
Country
Australia
Facility Name
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Québec
Country
Canada
Facility Name
Clinica San Carlos de Apoquindo Red Salud UC Christs
City
Santiago
Country
Chile
Facility Name
Fakultni nemocnice v Motole
City
Prague
Country
Czechia
Facility Name
Institut Bergonnié
City
Bordeaux
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Centre Oscar Lambret
City
Lille Cedex
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hopital La Timone
City
Marseille
Country
France
Facility Name
IPC
City
Marseille
Country
France
Facility Name
IGR
City
Paris
Country
France
Facility Name
CHU Poitiers-Hopital la Miletrie
City
Poitiers
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
Country
France
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
Country
Germany
Facility Name
Technische Universitat Dresden
City
Dresden
Country
Germany
Facility Name
West German Cancer Center
City
Essen
Country
Germany
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
Country
Hungary
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Be'er Ya'akov
Country
Israel
Facility Name
Rabin Medical Cente
City
Petah Tikva
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
City
Meldola
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
Country
Italy
Facility Name
Universita degli Studi di Palermo
City
Palermo
Country
Italy
Facility Name
Università Campus Bio-Medico di Roma
City
Rome
Country
Italy
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
Country
Netherlands
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Centre
City
Leiden
Country
Netherlands
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
City
Warsaw
Country
Poland
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario HM Madrid Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Instituto Valenciano de Oncología,
City
Valencia
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
Country
Spain
Facility Name
Karolinska universitetssjukhuset
City
Solna
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi
City
Lausanne
Country
Switzerland
Facility Name
Universitaetsspital Zuerich, Klinik fuer Onkologie
City
Zurich
Country
Switzerland
Facility Name
Chang Gung Memorial Hospital
City
Linkou
State/Province
Taoyuan County
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital,
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Chen Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Fulham
City
London
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35947817
Citation
Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Dec 1;40(34):3918-3928. doi: 10.1200/JCO.22.00294. Epub 2022 Aug 10.
Results Reference
derived
PubMed Identifier
31755321
Citation
Nemunaitis J, Bauer S, Blay JY, Choucair K, Gelderblom H, George S, Schoffski P, Mehren MV, Zalcberg J, Achour H, Ruiz-Soto R, Heinrich MC. Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib. Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.
Results Reference
derived
Links:
URL
http://www.deciphera.com
Description
Deciphera Company Website
Learn more about this trial
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
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