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

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ClinicalTrials.gov Identifier: NCT03465722
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Blueprint Medicines Corporation

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.

Condition or disease Intervention/treatment Phase
GIST Drug: avapritinib Drug: regorafenib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: avapritinib
300 mg PO QD
Drug: avapritinib
Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
Other Name: BLU-285

Active Comparator: regorafinib
160 mg PO QD
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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 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 2.

Exclusion Criteria:

  1. Patients who have received prior treatment with avapritinib or regorafenib.
  2. Patients who have received more than 3 different prior 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, thromboembolic disease, or significant risk of bleeding.
  6. Patients who have a non-healing wound, ulcer, 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.

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): NCT03465722


Contacts
Contact: Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com

  Show 25 Study Locations
Sponsors and Collaborators
Blueprint Medicines Corporation

Responsible Party: Blueprint Medicines Corporation
ClinicalTrials.gov Identifier: NCT03465722     History of Changes
Other Study ID Numbers: BLU-285-1303
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Blueprint Medicines Corporation:
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

Additional relevant MeSH terms:
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