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

Sponsor
Deciphera Pharmaceuticals LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03673501
Collaborator
(none)
426
Enrollment
121
Locations
2
Arms
36.6
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 11, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: DCC-2618

150 mg QD DCC-2618

Drug: DCC-2618
Oral KIT/PDGFRA kinase inhibitor
Other Names:
  • ripretinib

    		•
    Active Comparator: sunitinib

    50 mg QD sunitinib

    Drug: Sunitinib
    Oral receptor tyrosine kinase (RTK) inhibitor
    Other Names:
  • Sutent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [30 months]

      PFS Based on independent radiologic review using modified RECIST

    Secondary Outcome Measures

    1. Objective response rate (ORR) [30 months]

      Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review

    2. Overall Survival (OS) [30 months]

      Measure of overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 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

    1. Any active bleeding excluding hemorrhoidal or gum bleeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259
    2 University of California San Diego Medical Center La Jolla California United States 92103
    3 UCLA Hematology Oncology Center - Main Site Los Angeles California United States 90024
    4 Stanford Medicine Stanford California United States 94305
    5 University of Colorado Hospital - Anschutz Cancer Pavillion Aurora Colorado United States 80045
    6 Rocky Mountain Cancer Centers Denver Colorado United States 80220
    7 Smilow Cancer Hospital at Yale New Haven Connecticut United States 06511
    8 Washington Cancer Institute at MedStar Washington Hospital Center Washington District of Columbia United States 20010
    9 Mayo Clinic Florida Jacksonville Florida United States 32224
    10 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    11 Miami Cancer Institute at Baptist Health, Inc. Miami Florida United States 33176
    12 Orlando Health UF Health Cancer Center Orlando Florida United States 32806
    13 Moffitt Cancer Center Tampa Florida United States 33612
    14 Winship Cancer Institute Atlanta Georgia United States 30332
    15 Georgia Cancer Specialists Sandy Springs Georgia United States 30342
    16 Northwestern Memorial Hospital Chicago Illinois United States 60611
    17 University of Chicago Medical Center Chicago Illinois United States 60637
    18 IU Simon Cancer Center Indianapolis Indiana United States 46202
    19 University of Iowa Hospital and Clinics Iowa City Iowa United States 52242
    20 Norton Cancer Institute, Audubon Hospital Campus Louisville Kentucky United States 40241
    21 Johns Hopkins Hospital Baltimore Maryland United States 21287
    22 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    23 Henry Ford Health System Detroit Michigan United States 48202
    24 University of Minnesota Medical Center-Fairview Minneapolis Minnesota United States 55455
    25 Mayo Clinic Rochester Minnesota United States 55905
    26 Washington University School of Medicine - Siteman Cancer Center Saint Louis Missouri United States 63110
    27 Rutgers Cancer Institute New Brunswick New Jersey United States 08901
    28 Montefiore Medical Center-Montefiore Medical Park Bronx New York United States 10467
    29 Roswell Park Cancer Institute Buffalo New York United States 43606
    30 The Monter Cancer Center Lake Success New York United States 11042
    31 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    32 Duke University Medical Center Durham North Carolina United States 27710
    33 The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute Columbus Ohio United States 43210
    34 University of Toledo Toledo Ohio United States 43606
    35 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    36 Oregon Health & Science University Center for Health and Healing Portland Oregon United States 97239
    37 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    38 Henry-Joyce Cancer Clinic Nashville Tennessee United States 37232
    39 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    40 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    41 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298
    42 University of Washington Medical Center Seattle Washington United States 98195
    43 Froedtert Hospital-Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    44 Sanatorio Allende Córdoba Cordoba Argentina X5000JHQ
    45 Instituto Medicao Especializado Alexander Fleming Buenos Aires Argentina
    46 Border Medical Oncology Research Unit Albury New South Wales Australia
    47 Prince of Wales Hospital Randwick New South Wales Australia 2031
    48 Princess Alexandra Hospital Woolloongabba Queensland Australia
    49 Ashford Cancer Centre Research Kurralta Park South Australia Australia 5037
    50 Ashford Cancer Centre Research Kurralta Park South Australia Australia
    51 The Alfred Hospital Melbourne Victoria Australia 3004
    52 Princess Alexandara Hospital Woolloongabba Australia
    53 Institut Jules Bordet Bruxelles Belgium
    54 UZ Leuven Leuven Belgium
    55 Cross Cancer Institute Edmonton Alberta Canada
    56 CancerCare Manitoba Winnipeg Manitoba Canada
    57 Juravinski Cancer Centre Hamilton Ontario Canada
    58 The Ottawa Hospital Cancer Centre Ottawa Ontario Canada
    59 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2C1
    60 Hopital Maisonneuve-Rosemont Québec Canada
    61 Clinica San Carlos de Apoquindo Red Salud UC Christs Santiago Chile
    62 Fakultni nemocnice v Motole Prague Czechia
    63 Institut Bergonnié Bordeaux France
    64 Centre Georges François Leclerc Dijon France
    65 Centre Oscar Lambret Lille Cedex France
    66 Centre Léon Bérard Lyon France
    67 Hopital La Timone Marseille France
    68 IPC Marseille France
    69 IGR Paris France
    70 CHU Poitiers-Hopital la Miletrie Poitiers France
    71 ICO - Site René Gauducheau Saint Herblain France
    72 HELIOS Klinikum Berlin-Buch Berlin Germany
    73 Technische Universitat Dresden Dresden Germany
    74 West German Cancer Center Essen Germany
    75 Magyar Honvedseg Egeszsegugyi Kozpont Budapest Hungary
    76 Debreceni Egyetem Debrecen Hungary
    77 Shamir Medical Center (Assaf Harofeh) Be'er Ya'akov Israel
    78 Rabin Medical Cente Petah Tikva Israel
    79 Tel-Aviv Sourasky Medical Center Tel Aviv Israel
    80 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna Italy
    81 stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Meldola Italy
    82 Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
    83 IOV - Istituto Oncologico Veneto IRCCS Padova Italy
    84 Universita degli Studi di Palermo Palermo Italy
    85 Università Campus Bio-Medico di Roma Rome Italy
    86 Asan Medical Center Seoul Korea, Republic of
    87 Samsung Medical Center Seoul Korea, Republic of
    88 Seoul National University Hospital Seoul Korea, Republic of
    89 Ajou University Hospital Suwon Korea, Republic of
    90 Antoni van Leeuwenhoek Amsterdam Netherlands
    91 The Netherlands Cancer Institute Amsterdam Netherlands
    92 University Medical Center Groningen Groningen Netherlands
    93 Leiden University Medical Centre Leiden Netherlands
    94 Oslo University Hospital Oslo Norway
    95 Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Warsaw Poland
    96 National Cancer Centre Singapore Singapore 169610
    97 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    98 Hospital Universitari Vall d'Hebron Barcelona Spain
    99 Hospital de Basurto Bilbao Spain
    100 Hospital Universitario 12 de Octubre Madrid Spain
    101 Hospital Universitario Clinico San Carlos Madrid Spain
    102 Hospital Universitario HM Madrid Sanchinarro Madrid Spain
    103 Hospital Universitario La Paz Madrid Spain
    104 Hospital Universitario Ramon y Cajal Madrid Spain
    105 Hospital Clinico Universitario Virgen de la Victoria Malaga Spain
    106 Hospital Universitario Virgen del Rocio Sevilla Spain
    107 Instituto Valenciano de Oncología, Valencia Spain
    108 Complejo Hospitalario Universitario de Vigo Vigo Spain
    109 Karolinska universitetssjukhuset Solna Sweden
    110 Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi Lausanne Switzerland
    111 Universitaetsspital Zuerich, Klinik fuer Onkologie Zurich Switzerland
    112 Chang Gung Memorial Hospital Linkou Taoyuan County Taiwan
    113 Kaohsiung Chang Gung Memorial Hospital, Kaohsiung Taiwan
    114 China Medical University Hospital Taichung Taiwan
    115 National Chen Kung University Hospital Tainan Taiwan
    116 Taipei Veterans General Hospital Taipei Taiwan
    117 Beatson West of Scotland Cancer Centre Glasgow United Kingdom
    118 St James's University Hospital Leeds United Kingdom
    119 Royal Marsden Hospital - Fulham London United Kingdom
    120 University College London Hospitals London United Kingdom
    121 Weston Park Hospital Sheffield United Kingdom

    Sponsors and Collaborators

    • Deciphera Pharmaceuticals LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Deciphera Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT03673501
    Other Study ID Numbers:
    • DCC-2618-03-002
    First Posted:
    Sep 17, 2018
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Sunitinib

    Study Results

    No Results Posted as of Jan 6, 2021