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) - Not available

BLUEPRINT MEDICINES CORPORATIO0 个研究点目标入组 460 人开始时间: 2021年2月4日最近更新: 2021年10月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 460

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 clinical trial of medicinal product

入排标准

性别: All

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 as prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit, or intolerance. Additionally, disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy is allowed. 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 ECOG PS of 0 to 2. 5) Patient, or legal guardian if permitted by local regulatory authorities, who provides informed consent to participate in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 370
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

排除标准

•1. Patients who have received prior treatment with avapritinib or regor. 2) Patients who have received more than 3 different prior TKI treatment regimens. If a patient receives the same TKI more than once sequentially, that will be counted as a single TKI treatment regimen. 3) Patients who are known to be both KIT and PDGRFa wild type. 4) Patients who received any systemic anticancer therapy within 2w before randomization. Prior radiotherapy to major organs within 2w of randomization, or focal radiotherapy, such as to bones, limbs, or other areas not involving major organs, within 3d. 5) Patients who have clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure GII, III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6m, or uncontrolled hypertension. 6) Patients who have experienced arterial thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within the 6m before randomization or venous thrombotic events such as deep vein thrombosis within the 3m before randomization. 7) Patients who have experienced any hemorrhage or bleeding event NCI CTCAE v4.03 G3 or higher within 4w before randomization. 8) Patients who have a known risk of intracranial bleeding, such as a brain aneurysm or history of intracranial bleeding within one year prior to randomization. 9) Patients who have a non-healing wound, ulcer, or bone fracture. 10) Patients who have poor organ function as defined by one or more of the following laboratory parameters: Persistent proteinuria of NCI-CTCAE v4.03 G3 or higher; Alanine aminotransferase and AST > 3 × upper limit of normal (ULN) if no hepatic metastases are present; > 5 × ULN if hepatic metastases are present; Total bilirubin >1.5 × ULN; and in presence of Gilbert's syndrome, total bilirubin > 3 × ULN or direct bilirubin > 1.5 × ULN; Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 40 mL/min; Platelet count < 90 × 109/L and absolute neutrophil count (ANC) < 1.0 × 109/L; Hemoglobin < 9 g/dL. Transfusion and erythropoietin may be used to reach at least 9 g/dL, but must have been administered at least 2 weeks before randomization. 11) Patients who have received neutrophil growth factor support within 14 days of randomization. 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 randomization. Patient has significant traumatic injury within 28 days before randomization. 14) Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before randomization. (The following are exempt from the 3-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.) 15) Patients who have a history of a seizure disorder requiring antiseizure medication. 16) Patients who have metastases to the brain. 17) Patients who are unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions. 18) Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec 19) Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or emp

研究者

发起方

BLUEPRINT MEDICINES CORPORATIO

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