NCT03604679已完成1 期
A Multicenter, Open-label, Phase I Study of SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors:
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
- 18
- 试验地点
- 1
- 主要终点
- Identification of Dose-Limiting Toxicity (DLT) and Number of Subjects with DLT in Each Cohort/Level
研究概览
简要总结
This study is an open-label, multicenter, phase 1 study of SyB C-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. Part 1 is a dose escalation study to evaluate tolerability of SyB C-0501 in the patients, and to find the maximum tolerated dose (MTD), recommended dose (RD) and optimum dosing schedule. Part 2 is being done to evaluate safety and anti-tumor activity of SyB C-0501 preliminarily at RD, and to assess its target cancer exploratory.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or greater at the time of informed consent
- •Part 1: Patients with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies or without standard therapies.
- •Part 2: patients with advanced solid tumors* refractory to standard therapies or without standard therapies.
- •*metastatic breast cancer, small cell lung cancer and other tumors decided based on the Part 1 results
- •ECOG performance status 0-1
- •Patients with adequate bone marrow, liver, renal, cardiac and pulmonary function as assessed by the following:
- •Absolute neutrophil count (ANC) ≥ 1500/μL, who has not received supportive care of treatment with GCS within 2 weeks before the entry
- •Platelet count ≥ 100,000/μL and Hemoglobin ≥ 9g/dL in patients received no blood transfusions within 2 weeks before the study entry
- •Serum creatinine ≤ 1.5 x upper limit normal (ULN) or estimated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation
- •Serum total bilirubin ≤ 1.5 x ULN in patients not suffering from Gilbert's syndrome
- •ALT and AST ≤ 3.0 x ULN (≤ 5.0 x ULN if liver lesions)
- •12-lead ECG normal
- •LVEF ≥ 55% by echocardiography
- •SpO2 ≥ 95% or PaO2 ≥ 65mmHg
- •Acute toxicity in prior treatment has recovered to baseline or CTCAE Grade 0-1 except the adverse events that, in the judgment of the investigator or sub-investigator, would not provide safety risks in the study.
- •Serum/urine pregnancy tests performed before the study entry are negative.
- •Male and female patients of childbearing potential should give their consent to use adequate contraceptive measures during the study and 180 days after completing study treatment.
- •Provision of written, signed and dated informed consent by the patient or legally acceptable representative after the receipt of adequate information regarding the study
- •Ability to understand participation in the study, visiting/treatment plan, sampling/analyses and other study procedures; and willingness to follow them
排除标准
- •Active, uncontrollable or symptomatic metastatic tumors in CNS
- •Complications of interstitial lung disease, pulmonary fibrosis and emphysema diagnosed by chest-X ray or CT scan
- •Medical history of radiation, idiopathic or drug-induced pneumonitis
- •Major surgery within 4 weeks before study entry or planning it within 4 weeks
- •Treatment with immunotherapy, therapeutic antibody or biologics within 4 weeks or their 5 half-lives before study entry, whichever is longer
- •Treatment with cytocidal chemotherapy or hormonal therapy within 14 days
- •Radiotherapy within 4 weeks before study entry
- •Palliative radiotherapy to control metastatic bone pain within 7 days before study entry
- •Malabsorption syndrome or full/partial gastric resection
- •Patients intolerable to oral administration in the judgment of the investigator or sub-investigator
- •Patients under following medical treatment
- •Anticancer therapy approved for advanced cancers
- •Study treatment in other clinical trials
- •Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) detected in blood test
- •Lactating women
- •Medical history of allergy to the agents similar to the investigational drug such as alkylating agents or purine nucleoside derivatives
- •Medical history of allergy to Polyoxyl 40 hydrogenated castor oil or gelatin capsule
- •Severe acute or chronic physical/mental condition or laboratory abnormalities which could interfere with evaluation of study treatment or results, or which is likely to progress/worsen due to the participation in the study or administration of SyB C-0501
- •Any condition that, in the opinion of the investigator or sub-investigator, makes the patient inappropriate for the study participation.
研究组 & 干预措施
SyB C-0501
Experimental
SyB C-0501 (Oral Bendamustine) will be administered orally once a day (specified dose). The treatment period of 21 days (Cohort 1; 7 days of administration + 14 days of observation or Cohort 2; 14 days of administration + 7 days of observation or Cohort 3; 21 days of administration) constitutes 1 cycle.
Part 1: dose escalation to determine MTD, RD and dosing schedule Part 2: dose expansion at RD
干预措施: SyB C-0501 (Drug)
结局指标
主要结局
Identification of Dose-Limiting Toxicity (DLT) and Number of Subjects with DLT in Each Cohort/Level
时间窗: Cycle 1 (Approximately 3 weeks)
Based on the number of patients with DLT and administration dose in each cohort, recommended dosage will be defined for the following clinical phase. A DLT is defined as an adverse event that occurred during the Cycle 1, for which a causality with the investigational products (IP) cannot be ruled out and meets the DLT criteria of this study.
Adverse Events (Types, Incidence, severity, Relationship to SyB C-0501)
时间窗: Approximately 2 years
次要结局
- Change of laboratory test values and clinical laboratory abnormal values (Incidence, Severity)(Approximately 2 years)
- Adverse Events (Types, Incidence, Severity, Relationship to SyB C-0501)(Approximately 4 years)
- Maximum concentration (Cmax) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Time to maximum concentration (tmax) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day15 of Cycle 1 (each cycle is 21 days))
- Area under the concentration-time curve up to the last time point with detectable plasma concentration (AUC0-last) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Area under the concentration-time curve up to infinity (AUC0-inf) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Elimination half-life (t1/2) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Oral clearance (CL/F) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Apparent volume of distribution (Vd/F) of unchanged bendamustine in plasma(Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days))
- Objective Response Rate (ORR), Clinical benefit rate (CBR) and Progression-Free Survival (PFS)(Approximately 2 years)
研究者
研究点 (1)
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