NCT03465722已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 112
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are ≥ 18 years of age.
- •Patients who have histologically confirmed metastatic or unresectable GIST.
- •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.
- •Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
排除标准
- •Patients who have received prior treatment with avapritinib or regorafenib.
- •Patients who have previously received more than 3 different TKI treatment regimens.
- •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.
- •Patients who received any systemic anticancer therapy within 1 week before the first dose of study drug.
- •Patients who have clinically significant cardiovascular disease
- •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
- •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
- •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
- •Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.
- •Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
- •Patients who have received neutrophil growth factor support within 14 days of first dose of study drug.
- •Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A
- •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.
- •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.
- •Patients who have a history of a seizure disorder requiring anti-seizure medication.
- •Patients who have metastases to the brain.
- •Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
- •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.
- •Women who are pregnant.
- •Women who are breastfeeding.
- •Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.
研究组 & 干预措施
avapritinib
Experimental
300 mg PO QD
干预措施: avapritinib (Drug)
regorafenib
Active Comparator
160 mg PO QD
干预措施: regorafenib (Drug)
结局指标
主要结局
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
时间窗: 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. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.
次要结局
- Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1(24 Months)
- Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib(24 Months)
- European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib(Difference between baseline and week 12 of treatment)
研究者
研究点 (112)
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