NCT04577703已完成1 期
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ningetinib (CT053PTSA) in Patients With Advanced Solid Tumors: A Phase I, Single-arm, Single-center, Open-label, Dose-escalation Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a phase I, single-arm, single-center, open-label, dose-escalation Study evaluating the safety and efficacy of CT053PTSA in patients with Advanced Solid Tumors
详细描述
This is a dose-escalation study. The primary purpose is to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommend doses and regimen of CT053PTSA for further studies.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Subjects with advanced solid tumors confirmed by histologically or cytologically that are refractory to current treatment or for which there is not a current standard of care B. Toxicity recovered to NCI CTCAE v.4.0 Grade ≤1 from previous treatments (chemotherapy, radiotherapy or surgery) C. ECOG performance status (PS) 0 or 1 D. Life expectancy of ≥ 12 weeks E. Adequate organ function
- •Hemoglobin > 9 g/dL (SI Units: 90 g/L) without transfusion support or growth factors; Platelet count ≥ 100 × 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L without growth factor support.
- •AST/SGOT and/or ALT/SGPT≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0× ULN if liver metastases are present; serum bilirubin ≤ 1.5×ULN
- •Serum creatinine ≤ 1.5×ULN
- •Blood potassium≥ 3.0 mmol/L; serum calcium≥2.0 mmol/L
- •Fasting serum triglyceride level≤5.7 mmol/L
- •Asymptomatic abnormal serum amylase≤1.5×ULN
- •Serum lipase≤ ULN
- •INR≤ 1.5×ULN；APTT≤ 1.5×ULN； PT ≤ 1.5×ULN
排除标准
- •Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to study treatment
- •Nitrosourea, anthracyclinea and mitomycin chemotherapy within 6 weeks prior to study treatment
- •Had received live vaccine within 4 weeks prior to study treatment
- •Had received any investigational agent from other clinical study within 4 weeks prior to study treatment or are currently participating in other clinical trials
- •Previous treatment with any other c-MET inhibitor or HGF inhibitor
- •Symptomatic, untreated or unstable central nervous system metastases
- •Spinal cord compression, carcinomatous meningitis or leptomeningeal diseaseonly (patient are only permitted if treated, asymptomatic and stable for at least 4 weeks prior to start of study treatment)
- •Patients with hypertension that can't be well controlled by drugs (systolic blood pressure> 140 mmHg or diastolic blood pressure> 90 mmHg)
- •Doppler ultrasound evaluation：Left ventricular ejection fraction < 50%
- •Grade ≥ 2 of arrhythmia (assessed by NCI CTCAE 4.0), or symptomatic bradycardia, or male with QTCF > 450 ms or female with QTCF > 470 ms, or patients with a history of torsion or congenital QT prolonged syndrome long QT syndrome
- •Certain factors that would preclude adequate absorption of CT053PTSA (eg. unable to swallow, chronic diarrhea, intestinal obstruction)
- •Significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above
- •Patients with evidence of bleeding tendency, including the following cases: gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above; or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
- •History of immunodeficiency, or other acquired or congenital immunodeficiency, or history of organ transplantation
- •Any disease of the following bellowed within 12 months prior to administration: Myocardial infarction, severe angina, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure, or cerebrovascular events (including transient ischemic attack)
- •Pulmonary embolism within 6 months prior to administration
- •Active infection of hepatitis B, hepatitis C, or infection of HIV
- •Undergone a bone marrow or solid organ transplant.
- •Patients with severe retinopathy or exfoliation in the investigator's judgment
- •Patients need to be supplemented with stem cells before receiving large dose chemotherapy (except for myeloma or lymphoma)
- •History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.
- •Anticoagulants, vitamin K antagonists, other anti-tumor drugs and drugs that prolong the QT interval are not allowed.
- •Serious electrolyte imbalance in the investigator's judgment
- •Pregnant or lactating woman
- •Any other reason the investigator considers the patient is not suitable to participate in the study
研究组 & 干预措施
CT053PTSA (dose escalation)
Experimental
Patients were treated in 5 dose cohorts of 15 mg, 30 mg, 60 mg, 100 mg, and 150 mg QD capsules.
Patients receive treatment with CT053PTSA once on Cycle 0 Day 1 following a 7-day treatment-free withdrawal period to observe the safety and pharmacokinetic of CT053PTSA.
After that, Patients receive treatment with CT053PTSA per orally, beginning on Cycle 1 Day 1 for 28 day following a 7-day treatment-free withdrawal period to observe efficacy of CT053PTSA and determine to continue taking medicine or not. Each cycle had 28 days.
干预措施: CT053PTSA (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Cycle 0 Day 1 to Cycle 1 Day 28
The maximum tolerated dose (MTD) of the CT053PTSA will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0
次要结局
- Pharmacokinetics (PK) of CT053PTSA_Tmax(Cycle 0 Day 1 to Cycle 1 Day 28)
- Efficacy of CT053PTSA_ORR(up to approximately 36 months)
- Pharmacokinetics (PK) of CT053PTSA_AUC(Cycle 0 Day 1 to Cycle 1 Day 28)
- Efficacy of CT053PTSA_DCR(up to approximately 36 months)
- Pharmacokinetics (PK) of CT053PTSA_Cmax(Cycle 0 Day 1 to Cycle 1 Day 28)
研究者
研究点 (1)
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