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) - BLU-285-1303

Blueprint Medicines Corporation0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Blueprint Medicines Corporation
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Patients who are * 18 years of age.
•2. Patients who have GIST, which is histologically confirmed metastatic and/or
•unresectable (confirmed to be unresectable by a qualified surgeon).
•3. Patients who received imatinib and 1 or 2 other TKIs for the treatment of
•GIST, including TKIs used for adjuvant therapy. Each different TKI is counted
•once regardless of how often it was used, and if two different TKIs are used in
•combination, both TKIs are counted. Patients must have disease progression
•prior to enrollment. Prior use of other systemic and local therapies is not
•restricted.
•4. Patients who have an ECOG PS of 0 to 1.
•5. Patients, or legal guardian if permitted by local regulatory authorities,
•who provides informed consent to participate in the study.

排除标准

•1. Patients who have received prior treatment with avapritinib or regorafenib.
•2. Patients who have received more than 3 different TKIs for the treatment of
•GIST, including TKIs used for adjuvant therapy. Each different TKI is counted
•once regardless of how often it was used, and if two different TKIs are used in
•combination, both TKIs are counted.
•3. Patients who are known to be both KIT and PDGRF* wild type.
•4. Patients who received any systemic anticancer therapy within 1 week before
•the first dose of study drug. Prior radiotherapy (including stereotactic
•radiotherapy) to major organs within 2 weeks of the first dose of study drug,
•or focal radiotherapy, (including stereotactic radiotherapy), such as to
•bones, limbs, or other areas not involving major organs, within 3 days.
•5. Patients who have clinically significant, uncontrolled, cardiovascular
•disease, including congestive heart failure Grades II, III or IV according to
•the New York Heart Association classification, myocardial infarction or
•unstable angina within the previous 6 months, or uncontrolled
•hypertension.
•6. Patients who have experienced arterial thrombotic or embolic events such as
•cerebrovascular accident within 6 months before the first dose of study drug,
•or venous thrombotic events such as pulmonary embolism within the 14 days
•before the first dose of study drug or deep vein thrombosis within 14 days
•before the first dose of study drug. Patients with venous thrombotic events
•such as pulmonary embolism or deep vein thrombosis * 14 days before the first
•dose of study drug are not excluded provided they are on stabel dosis of
•anticoagulation, or have completed the planned coagulation regimen.
•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
•8. Patients who have a known risk of intracranial bleeding, such as a brain
•aneurysm that has not been removed or repaired, or history of intracranial
•bleeding within one year prior to randomization.
•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 one or more laboratory
•parameters, as described in the protocol.
•11. Patients who have received neutrophil growth factor support within 14 days
•of the first dose of study drug.
•12. Patients who require therapy with a concomitant medication that is a strong
•inhibitor or strong or moderate 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 the first dose of study
•drug. The following prior malignancies are not exclusionary: completely
•resected basal cell and squamous cell skin cancer, curatively treated localized
•prostate cancer, and completely resected carcinoma in situ of any site.
•Patients with a prior or concurrent malignancy whose natural history or
•treatment does not have the potential to interfere with the safety or efficacy
•assessment of the investigational agent may be included after approval by

研究者

发起方

Blueprint Medicines Corporation

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