NCT06640361招募中3 期
A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS) rate
研究概览
简要总结
An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.
详细描述
This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.
- •Must have at least one measurable target lesion.
- •Expected survival of at least 3 months.
- •Adequate organ function.
- •Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.
- •Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.
- •Prior to initiation of any screening or study-specific procedures, the patient or his/her guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.
排除标准
- •Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.
- •Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
- •Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
- •Adverse events due to prior treatment have not recovered (> NCI CTCAE v5.0 Grade 1).
- •Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
- •With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.
- •Poorly controlled hypertension after hypertension medication.
- •Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.
- •Uncontrolled Hyperlipidemia.
- •Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.
- •With brain metastases.
- •Other malignancies within 2 years.
- •Uncontrolled systemic active fungal, bacterial, and/or viral infections.
- •Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.
- •Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.
研究组 & 干预措施
Olverembatinib
Experimental
干预措施: Olverembatinib (Drug)
结局指标
主要结局
Progression-free survival(PFS) rate
时间窗: 36 months
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
次要结局
- Plasma concentrations of olverembatinib(Cycle 2 to Cycle 3 (each cycle is 28 days))
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.(Through study completion,an average of 2 years.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
ong-term safety of Z-338 in Patients with Functional Dyspepsia (Condition that causes an upset stomach or pain or discomfort in the upper abdomen).MedDRA version: 19.0Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 100000004856Functional DyspepsiaEUCTR2013-003342-16-LTZeria Pharmaceutical Co., Ltd.300
进行中（未招募）
1 期
ong-term safety of Z-338 in Patients with Functional Dyspepsia (Condition that causes an upset stomach or pain or discomfort in the upper abdomen).MedDRA version: 16.1Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 100000004856Functional DyspepsiaEUCTR2013-003342-16-BEZeria Pharmaceutical Co., Ltd.500
进行中（未招募）
1 期
ong-term safety of Z-338 in Patients with Functional Dyspepsia (Condition that causes an upset stomach or pain or discomfort in the upper abdomen).MedDRA version: 18.0Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 100000004856Functional DyspepsiaEUCTR2013-003342-16-SKZeria Pharmaceutical Co., Ltd.207
进行中（未招募）
1 期
ong-term safety of Z-338 in Patients with Functional Dyspepsia (Condition that causes an upset stomach or pain or discomfort in the upper abdomen).Functional DyspepsiaEUCTR2013-003342-16-GBZeria Pharmaceutical Co., Ltd.207
进行中（未招募）
1 期
ong-term safety of Z-338 in Patients with Functional Dyspepsia (Condition that causes an upset stomach or pain or discomfort in the upper abdomen).MedDRA version: 17.1Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 100000004856Functional DyspepsiaEUCTR2013-003342-16-LVZeria Pharmaceutical Co., Ltd.500