Clinical Trials /

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

NCT03465722

Description:

This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
  • Official Title: An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Clinical Trial IDs

  • ORG STUDY ID: BLU-285-1303
  • NCT ID: NCT03465722

Conditions

  • GIST

Interventions

DrugSynonymsArms
avapritinibBLU-285avapritinib
regorafenibStivargaregorafinib

Purpose

This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

Trial Arms

NameTypeDescriptionInterventions
avapritinibExperimental300 mg PO QD
  • avapritinib
regorafinibActive Comparator160 mg PO QD
  • regorafenib

Eligibility Criteria

        Inclusion Criteria:

          1. Patients who are ≥ 18 years of age.

          2. Patients who have histologically confirmed metastatic or unresectable GIST.

          3. Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens.
             Patients who experienced intolerance to prior therapies must have objective disease
             progression prior to enrollment onto BLU-285-1303 study.

          4. Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS)
             of 0 to 1.

        Exclusion Criteria:

          1. Patients who have received prior treatment with avapritinib or regorafenib.

          2. Patients who have previously received more than 3 different TKI treatment regimens.

          3. Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral
             oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild
             type.

          4. Patients who received any systemic anticancer therapy within 2 weeks before
             randomization.

          5. Patients with clinically significant cardiovascular disease, uncontrolled
             thromboembolic disease, or significant risk of bleeding.

          6. Patients who have a non-healing wound, ulcer, gastrointestinal perforation, or bone
             fracture.

          7. Patients who have poor organ function as defined by laboratory parameters specified in
             the protocol.

          8. Patients who have received neutrophil growth factor support within 14 days of
             randomization.

          9. Patients who require therapy with a concomitant medication that is a strong inhibitor
             or strong inducer of CYP3A4.

         10. Patients who have had a major surgical procedure within 14 days of randomization.
             Patient has significant traumatic injury within 28 days before randomization.

         11. Patients who have a history of another primary malignancy that has been diagnosed or
             required therapy within 3 years before randomization.

         12. Patients who have a history of a seizure disorder requiring anti-seizure medication.

         13. Patients who have metastases to the brain.

         14. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450
             msec.

         15. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from
             sexual intercourse or employ highly effective contraception from the time of
             randomization and for at least 30 days after the last dose of study drug. Men who are
             unwilling, if not surgically sterile, to abstain from sexual intercourse or employ
             highly effective contraception from the time of randomization and for at least 90 days
             after the last dose of study drug.

         16. Women who are pregnant.

         17. Women who are breastfeeding.

         18. Patients who have prior or ongoing clinically significant illness, medical condition,
             surgical history, physical finding, or laboratory abnormality as determined by the
             investigator.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1
Time Frame:24 Months
Safety Issue:
Description:To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) determined by central radiology assessment per mRECIST, version 1.1
Time Frame:24 Months
Safety Issue:
Description:To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Measure:Overall Survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame:60 Months
Safety Issue:
Description:To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Measure:European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) physical functioning score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame:12 Weeks
Safety Issue:
Description:To evaluate the mean change from baseline to week 12 in European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) physical functioning score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Measure:EORTC-QLQ-C30 pain score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame:12 Weeks
Safety Issue:
Description:To evaluate the mean change from baseline to week 12 in EORTC-QLQ-C30 pain score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Measure:EORTC-QLQ-C30 role functioning score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame:12 Weeks
Safety Issue:
Description:To evaluate the mean change from baseline to week 12 in EORTC-QLQ-C30 role functioning score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Measure:EORTC-QLQ-C30 appetite loss score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame:12 Weeks
Safety Issue:
Description:To evaluate the mean change from baseline to week 12 in EORTC-QLQ-C30 appetite loss score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Blueprint Medicines Corporation

Trial Keywords

  • Other Relapsed or Refractory Solid Tumors
  • BLU-285
  • BLU 285
  • BLUE-285
  • BLUE 285
  • Avapritinib
  • GIST imatinib relapse
  • GIST gleevec relapse
  • GIST KIT
  • GIST relapse
  • GIST refractory
  • GIST imatinib intolerance
  • GIST TKI treatment
  • GIST tyrosine kinase inhibitor treatment
  • GIST TKI
  • GIST tyrosine kinase inhibitor
  • Advanced GIST
  • GIST mutations
  • GIST treatments
  • Blueprint GIST
  • Relapsed GIST clinical trial
  • Refractory GIST clinical trial
  • KIT-mutant GIST
  • cancer gist
  • gastrointestinal stromal tumor
  • gist cancer
  • PDGFRA

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