Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

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

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.


Eligibility: 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.

Relevance to patient case: not relevant