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Trial record 1 of 1 for:    VOYAGER, blueprint
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(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465722
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Blueprint Medicines Corporation

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE March 26, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • Objective Response Rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 [ Time Frame: 24 Months ]
    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
  • Overall Survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 60 Months ]
    To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
  • European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30) individual scores in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 12 Weeks ]
    To evaluate mean change from baseline to week 12 in the EORTC-QLQ-30 individual scores in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Objective Response Rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 [ Time Frame: 24 Months ]
    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
  • Overall Survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 60 Months ]
    To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
  • 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 ]
    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
  • EORTC-QLQ-C30 pain score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 12 Weeks ]
    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
  • EORTC-QLQ-C30 role functioning score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 12 Weeks ]
    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
  • EORTC-QLQ-C30 appetite loss score in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 12 Weeks ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
Official Title  ICMJE 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)
Brief Summary 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.
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 GIST
Intervention  ICMJE
  • Drug: avapritinib
    Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    Other Name: BLU-285
  • Drug: regorafenib
    Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    Other Name: Stivarga
Study Arms  ICMJE
  • Experimental: avapritinib
    300 mg PO QD
    Intervention: Drug: avapritinib
  • Active Comparator: regorafinib
    160 mg PO QD
    Intervention: Drug: regorafenib
Publications * Gebreyohannes YK, Wozniak A, Zhai ME, Wellens J, Cornillie J, Vanleeuw U, Evans E, Gardino AK, Lengauer C, Debiec-Rychter M, Sciot R, Schöffski P. Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors. Clin Cancer Res. 2019 Jan 15;25(2):609-618. doi: 10.1158/1078-0432.CCR-18-1858. Epub 2018 Oct 1.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)
476
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
460
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 1 week before the first dose of study drug.
  5. Patients who have clinically significant cardiovascular disease
  6. Patients have experienced arterial thrombotic or embolic events within 6 months before the first dose of study drug, or venous thrombotic events within 14 days of the first dose of study drug
  7. Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before the first dose of study drug
  8. Patients who have a known risk of intracranial bleeding, or a history of intracranial bleeding within 1 year prior to the first dose of study drug
  9. Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.
  10. Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
  11. Patients who have received neutrophil growth factor support within 14 days of first dose of study drug.
  12. Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
  13. Patients who have had a major surgical procedure within 14 days of the first dose of study drug. Patient has significant traumatic injury within 28 days before the first dose of study drug.
  14. Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before first dose of study drug.
  15. Patients who have a history of a seizure disorder requiring anti-seizure medication.
  16. Patients who have metastases to the brain.
  17. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
  18. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 60 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 the first dose of study drug and for at least 90 days after the last dose of study drug.
  19. Women who are pregnant.
  20. Women who are breastfeeding.
  21. Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   China,   Czechia,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465722
Other Study ID Numbers  ICMJE BLU-285-1303
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 Not Provided
Responsible Party Blueprint Medicines Corporation
Study Sponsor  ICMJE Blueprint Medicines Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Blueprint Medicines Corporation
Verification Date November 2019

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