Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu
Trial record 1 of 4 for:    DCC | GIST
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03673501
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : February 20, 2020
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 358 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 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.

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

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.

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 identifier (NCT number): NCT03673501

Layout table for location contacts
Contact: Clinical Team 785-830-2100

Hide Hide 106 study locations
Layout table for location information
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mahesh Seetharam         
United States, California
University of California San Diego Medical Center Recruiting
La Jolla, California, United States, 92103
Contact: Adam Burgoyne         
UCLA Hematology Oncology Center - Main Site Recruiting
Los Angeles, California, United States, 90024
Contact: Arun Singh         
Stanford Medicine Recruiting
Stanford, California, United States, 94305
Contact: Kristen Ganjoo         
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavillion Recruiting
Aurora, Colorado, United States, 80045
Contact: Anthony Elias         
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80220
Contact: Allen Cohn         
United States, Connecticut
Smilow Cancer Hospital at Yale Recruiting
New Haven, Connecticut, United States, 06511
Contact: Hari Deshpande         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Attia    904-953-7292      
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Jonathan Trent         
Miami Cancer Institute at Baptist Health, Inc. Recruiting
Miami, Florida, United States, 33176
Contact: Santiago Aparo         
Principal Investigator: Santiago Aparo         
Orlando Health UF Health Cancer Center Recruiting
Orlando, Florida, United States, 32806
Contact: Thomas Sajeve         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Mihaela Druta         
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30332
Contact: William Read         
Georgia Cancer Specialists Recruiting
Sandy Springs, Georgia, United States, 30342
Contact: Bordoni         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Agulnik         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Hedy Kindler         
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Daniel Rushing         
United States, Iowa
University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Varun Monga         
United States, Kentucky
Norton Cancer Institute, Audubon Hospital Campus Recruiting
Louisville, Kentucky, United States, 40241
Contact: John Hamm         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Christian Meyer         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Suzanne George         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Ira Wollner         
United States, Minnesota
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Keith Skubitz         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Siontis         
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brian Van Tine         
United States, New York
Montefiore Medical Center-Montefiore Medical Park Recruiting
Bronx, New York, United States, 10467
Contact: Jennifer Chuy         
The Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Contact: Tony Philip         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ping Chi         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Richard Riedel         
United States, Ohio
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Gabriel Tinoco         
University of Toledo Completed
Toledo, Ohio, United States, 43606
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sagila George         
United States, Oregon
Oregon Health & Science University Center for Health and Healing Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Heinrich         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: vonMehren         
United States, Tennessee
Henry-Joyce Cancer Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vicki Keedy         
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Paulson         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Neeta Somaiah         
United States, Virginia
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Reilley         
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Sosipatros Boikos         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Michael Wagner         
United States, Wisconsin
Froedtert Hospital-Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: John Charlson         
Sanatorio Allende Recruiting
Córdoba, Cordoba, Argentina, X5000JHQ
Contact: Gustavo Jarchum         
Instituto Medicao Especializado Alexander Fleming Recruiting
Buenos Aires, Argentina
Contact: Matias Chacon         
Australia, New South Wales
Border Medical Oncology Research Unit Recruiting
Albury, New South Wales, Australia
Contact: Craig Underhill         
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: David Goldstein         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia
Contact: Warren Joubert         
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact: Dusan Kotasek         
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia
Contact: Sarwan Bishnoi         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: John Zalcberg         
Institut Jules Bordet Recruiting
Bruxelles, Belgium
Contact: Thierry Gil         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Patrick Schoffski         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Karen Mulder         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Shantanu Banerji         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada
Contact: Kevin Zbuk         
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada
Contact: Timothy Asmis         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Albiruni Razak         
Clinica San Carlos de Apoquindo Red Salud UC Christs Recruiting
Santiago, Chile
Contact: Marcelo Adan Garrido Salvo         
Fakultni nemocnice v Motole Recruiting
Prague, Czechia
Contact: Jana Prausova         
Institut Bergonnié Recruiting
Bordeaux, France
Contact: Antoine Italiano         
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: Alice Hervieu         
Centre Oscar Lambret Recruiting
Lille Cedex, France
Contact: Nicolas Penel         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Jean-Yves Blay         
Hopital La Timone Recruiting
Marseille, France
Contact: Florence Duffaud         
IPC Recruiting
Marseille, France
Contact: Francois Bertucci         
IGR Recruiting
Paris, France
Contact: Axel Le Cesne         
ICO - Site René Gauducheau Recruiting
Saint Herblain, France
Contact: Emmanuelle Bompas         
HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany
Contact: Peter Reichardt         
West German Cancer Center Recruiting
Essen, Germany
Contact: Sebastian Bauer         
Magyar Honvedseg Egeszsegugyi Kozpont Recruiting
Budapest, Hungary
Contact: Zsuzsanna Papai         
Debreceni Egyetem Recruiting
Debrecen, Hungary
Contact: Peter Arkosy         
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy
Contact: Maria Pantaleo         
stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Recruiting
Meldola, Italy
Contact: Toni Ibrahim         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy
Contact: Elena Fumagalli         
IOV - Istituto Oncologico Veneto IRCCS Recruiting
Padova, Italy
Contact: Antonella Brunello         
Università Campus Bio-Medico di Roma Recruiting
Rome, Italy
Contact: Bruno Vincenzi         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yoon-Koo Kang         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joon Oh Park         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung-Hun Lee         
Principal Investigator: Tae-Young Kim         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Seok Yun Kang         
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands
Contact: Ingrid Desar         
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Contact: Neeltje Steeghs         
Leiden University Medical Centre Recruiting
Leiden, Netherlands
Contact: Hans Gelderblom         
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Kjetil Boye         
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Recruiting
Warsaw, Poland
Contact: Piotr Rutowski         
National Cancer Centre Recruiting
Singapore, Singapore, 169610
Contact: Nagavalli Somasundaram         
Principal Investigator: Eileen Poon Ying Ling         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Antonio Lopez Pousa         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Cesar Garcia Serrano         
Hospital de Basurto Recruiting
Bilbao, Spain
Contact: Maria Angelas Sala Gonzalez         
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain
Contact: Antonio Casado Herraez         
Hospital Universitario HM Madrid Sanchinarro Recruiting
Madrid, Spain
Contact: Antonio Cubillo Gracian         
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Virginia Martinez Marin         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Maria Angeles Vaz Salgado         
Hospital Clinico Universitario Virgen de la Victoria Recruiting
Malaga, Spain
Contact: Isabel Garcia Sevilla         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Contact: Nadia Hindi         
Instituto Valenciano de Oncología, Recruiting
Valencia, Spain
Contact: Javier Lavernia Giner         
Complejo Hospitalario Universitario de Vigo Recruiting
Vigo, Spain
Contact: Juan Antonio Carrasco Alvarez         
Karolinska universitetssjukhuset Recruiting
Solna, Sweden
Contact: Antroula Papakonstantinou         
Chang Gung Memorial Hospital Recruiting
Linkou, Taoyuan County, Taiwan
Contact: Chun-Nan Yeh         
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Li-Yuan Bai         
National Chen Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Chia-Jui Yen         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Yen Chueh-Chuan         
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Contact: Jeffrey White         
St James's University Hospital Recruiting
Leeds, United Kingdom
Contact: Daniel Stark         
Royal Marsden Hospital - Fulham Recruiting
London, United Kingdom
Contact: Robin Jones         
University College London Hospitals Recruiting
London, United Kingdom
Contact: Palma Dileo         
Weston Park Hospital Recruiting
Sheffield, United Kingdom
Contact: Robin Young         
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deciphera Pharmaceuticals LLC Identifier: NCT03673501    
Other Study ID Numbers: DCC-2618-03-002
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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