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

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ClinicalTrials.gov Identifier: NCT03673501
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Tracking Information
First Submitted Date  ICMJE September 13, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Progression free survival (PFS) [ Time Frame: 30 months ]
PFS Based on independent radiologic review using modified RECIST
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03673501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Objective response rate (ORR) [ Time Frame: 30 months ]
    Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review
  • Overall Survival (OS) [ Time Frame: 30 months ]
    Measure of overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE
  • Drug: ripretinib
    Oral KIT/PDGFRA kinase inhibitor
    Other Name: DCC-2618
  • Drug: Sunitinib
    Oral receptor tyrosine kinase (RTK) inhibitor
    Other Name: Sutent
Study Arms  ICMJE
  • Experimental: ripretinib
    150 mg QD ripretinib
    Intervention: Drug: ripretinib
  • Active Comparator: sunitinib
    50 mg QD sunitinib
    Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
358
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 slide 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 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.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Team 785-830-2100 clinicaltrials@deciphera.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Norway,   Poland,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03673501
Other Study ID Numbers  ICMJE DCC-2618-03-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deciphera Pharmaceuticals LLC
Study Sponsor  ICMJE Deciphera Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Deciphera Pharmaceuticals LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP