NCT03594422招募中1 期
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Safety and tolerance
研究概览
简要总结
This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.
详细描述
The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or not pregnant or lactating women, age≥12years.
- •Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).
- •Estimated survival at least 3 months.
- •Adequate hematologic and bone marrow functions.
- •Adequate renal and liver function.
- •Heart function index:
- •Troponin(I/T) ≤ Upper Limit of Normal;
- •Ejection fraction >40%;
- •QTc interval ≤ 450 ms in male or ≤ 470 ms in female.
- •Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.
- •Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.
- •Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
- •Willing and ability to comply with study procedures and follow-up examination.
排除标准
- •Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP
- •Received any TKIs within 14 days before first dose of HQP
- •Attended any clinical trials on other drugs within 14 days before first dose of HQP
- •Have not recovered (> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
- •Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
- •Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.
- •Hypertension was still poorly controlled after medication treatment (SBP > 140 mmHg and/or DBP > 90 mmHg).
- •Concurrent use any medication led to prolong QT interval.
- •Pulmonary mean arterial pressure>35 mmHg by ECHO.
- •Significant severe cardiovascular conditions during previous TKI treatment.
- •Uncontrollable hypertriglyceridemia.
- •Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP
- •Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP
- •Brain metastasis.
- •Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).
- •Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.
- •Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.
- •Pregnancy or lactation, or expect to be pregnant during the study period.
- •According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.
- •Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
研究组 & 干预措施
HQP1351 30mg
Experimental
30 mg QOD(Minor subjects will be enrolled based on weight)
干预措施: HQP1351 (Drug)
HQP1351 40mg
Experimental
40 mg QOD(Minor subjects will be enrolled based on weight)
干预措施: HQP1351 (Drug)
HQP1351 50mg
Experimental
50 mg QOD
干预措施: HQP1351 (Drug)
HQP1351 20mg
Experimental
20 mg QOD (Minor subjects will be enrolled based on weight)
干预措施: HQP1351 (Drug)
结局指标
主要结局
Safety and tolerance
时间窗: 30 days after the last dose of HQP1351
Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.
次要结局
- Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.(28 days)
- Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.(28 days)
- Anti-tumor activities of HQP1351(3-60 months)
研究者
研究点 (6)
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