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Trial record 128 of 350 for:    Gastrointestinal Stromal Tumors
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A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (INTRIGUE)

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ClinicalTrials.gov Identifier: NCT03673501
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Results First Posted : January 2, 2024
Last Update Posted : January 2, 2024
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Study Description
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Brief Summary:
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib 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 ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Ripretinib Drug: Sunitinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 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 Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
 Drug: Ripretinib
Oral KIT/PDGFRA kinase inhibitor
Other Name: DCC-2618
Active Comparator: Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
 Drug: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Other Name: Sutent


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population [ Time Frame: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) ]
    PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  2. Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population [ Time Frame: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years) ]
    PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population [ Time Frame: From confirmed CR or PR to disease progression (up to 1.74 years) ]
    ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.

  2. Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population [ Time Frame: From confirmed CR or PR to disease progression (up to 1.74 years) ]
    ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.

  3. Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population [ Time Frame: From date of randomization until death due to any cause (up to 3.33 years) ]
    OS was defined as the time from the date of randomization until death due to any cause.

  4. Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population [ Time Frame: From date of randomization until death due to any cause (up to 3.33 years) ]
    OS was defined as the time from the date of randomization until death due to any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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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) Performance Score (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 Modified Response Evaluation Criteria in Solid Tumors (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 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 breast cancer resistance protein (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.
Contacts and Locations
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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
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Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
  Study Documents (Full-Text)

Documents provided by Deciphera Pharmaceuticals LLC:
Study Protocol  [PDF] October 23, 2020
Statistical Analysis Plan  [PDF] August 25, 2021

More Information
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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
Results First Posted: January 2, 2024
Last Update Posted: January 2, 2024
Last Verified: December 2023
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