Clinical Trials /

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

NCT03673501

Description:

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).

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: DCC-2618-03-002
  • NCT ID: NCT03673501

Conditions

  • Gastrointestinal Stromal Tumors

Interventions

DrugSynonymsArms
DCC-2618DCC-2618
SunitinibSutentsunitinib

Purpose

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) or sunitinib 50 mg QD, 4 weeks on, 2 weeks off.

Trial Arms

NameTypeDescriptionInterventions
DCC-2618Experimental150 mg QD DCC-2618
  • DCC-2618
sunitinibActive Comparator50 mg QD sunitinib
  • Sunitinib

Eligibility 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. Patients randomized to the DCC-2618 arm must agree to not use the prohibited
             medications. Patients must avoid ingestion of grapefruit or grapefruit juice.

          7. 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.

          8. Patients of reproductive potential must agree to follow the contraception requirements
             outlined in the study protocol.

          9. 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.

         10. Adequate organ function and bone marrow reserve as indicated by the central laboratory
             assessments performed at screening.

         11. 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).

         12. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:30 months
Safety Issue:
Description:PFS Based on independent radiologic review using modified RECIST

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:30 months
Safety Issue:
Description:Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review
Measure:Overall Survival (OS)
Time Frame:30 months
Safety Issue:
Description:Measure of overall survival

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Deciphera Pharmaceuticals LLC

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