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A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03673501
Recruitment Status : Unknown
Verified January 2021 by Deciphera Pharmaceuticals LLC.
Recruitment status was:  Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

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).

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: DCC-2618 Drug: Sunitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: DCC-2618
150 mg QD DCC-2618
Drug: DCC-2618
Oral KIT/PDGFRA kinase inhibitor
Other Name: ripretinib

Active Comparator: sunitinib
50 mg QD sunitinib
Drug: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Other Name: Sutent




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 30 months ]
    PFS Based on independent radiologic review using modified RECIST


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 30 months ]
    Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review

  2. Overall Survival (OS) [ Time Frame: 30 months ]
    Measure of overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years of age at the time of informed consent.
  2. Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
  3. 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.
  4. Patients must have progressed on imatinib or have documented intolerance to imatinib.
  5. Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
  6. 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.
  7. Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
  8. 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.
  9. Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
  10. 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).
  11. 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:

  1. 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.
  2. 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.
  3. Patient has known active central nervous system metastases.
  4. 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.
  5. Left ventricular ejection fraction (LVEF) < 50% at screening.
  6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
  7. 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.
  8. 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
  9. 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.
  10. 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.
  11. Any other clinically significant comorbidities.
  12. 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.
  13. If female, the patient is pregnant or lactating.
  14. Known allergy or hypersensitivity to any component of the study drug.
  15. Gastrointestinal abnormalities including but not limited to:

    • inability to take oral medication
    • malabsorption syndromes
    • requirement for intravenous (IV) alimentation
  16. Any active bleeding excluding hemorrhoidal or gum bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673501


Locations
Hide Hide 121 study locations
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United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92103
UCLA Hematology Oncology Center - Main Site
Los Angeles, California, United States, 90024
Stanford Medicine
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, Connecticut
Smilow Cancer Hospital at Yale
New Haven, Connecticut, United States, 06511
United States, District of Columbia
Washington Cancer Institute at MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Orlando Health UF Health Cancer Center
Orlando, Florida, United States, 32806
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30332
Georgia Cancer Specialists
Sandy Springs, Georgia, United States, 30342
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky, United States, 40241
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center-Montefiore Medical Park
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 43606
The Monter Cancer Center
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
University of Toledo
Toledo, Ohio, United States, 43606
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University Center for Health and Healing
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Froedtert Hospital-Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Sanatorio Allende
Córdoba, Cordoba, Argentina, X5000JHQ
Instituto Medicao Especializado Alexander Fleming
Buenos Aires, Argentina
Australia, New South Wales
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia
Princess Alexandara Hospital
Woolloongabba, Australia
Belgium
Institut Jules Bordet
Bruxelles, Belgium
UZ Leuven
Leuven, Belgium
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Canada
Hopital Maisonneuve-Rosemont
Québec, Canada
Chile
Clinica San Carlos de Apoquindo Red Salud UC Christs
Santiago, Chile
Czechia
Fakultni nemocnice v Motole
Prague, Czechia
France
Institut Bergonnié
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille Cedex, France
Centre Léon Bérard
Lyon, France
Hopital La Timone
Marseille, France
IPC
Marseille, France
IGR
Paris, France
CHU Poitiers-Hopital la Miletrie
Poitiers, France
ICO - Site René Gauducheau
Saint Herblain, France
Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Technische Universitat Dresden
Dresden, Germany
West German Cancer Center
Essen, Germany
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Israel
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov, Israel
Rabin Medical Cente
Petah Tikva, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy
stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy
Universita degli Studi di Palermo
Palermo, Italy
Università Campus Bio-Medico di Roma
Rome, Italy
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Norway
Oslo University Hospital
Oslo, Norway
Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, Poland
Singapore
National Cancer Centre
Singapore, Singapore, 169610
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Instituto Valenciano de Oncología,
Valencia, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
Sweden
Karolinska universitetssjukhuset
Solna, Sweden
Switzerland
Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi
Lausanne, Switzerland
Universitaetsspital Zuerich, Klinik fuer Onkologie
Zurich, Switzerland
Taiwan
Chang Gung Memorial Hospital
Linkou, Taoyuan County, Taiwan
Kaohsiung Chang Gung Memorial Hospital,
Kaohsiung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Chen Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Royal Marsden Hospital - Fulham
London, United Kingdom
University College London Hospitals
London, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03673501    
Other Study ID Numbers: DCC-2618-03-002
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action