Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients.
Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to 4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for 3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day. Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and administered for 4,800mg / day and complete the study after observation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 19 years
- •Patients with histologically or cytologically confirmed lung cancer or breast cancer for which standard curative measures do not exist or are no longer effective
- •Patients who have not received chemotherapy, radiotherapy or surgery within the last 4 weeks and no residual toxicity associated with the previous treatment (Grade 1 or higher adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0 from the National Cancer Institute (NCI)
- •ECOG Performance Status ≤ 2
- •Life expectancy estimated to be at least 12 weeks
- •Patients with the ability to swallow tablets
- •Patients with measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Patients with proper organ function as follows i. Bone marrow function: haemoglobin ≥8 g/dL, absolute neutrophil count ≥1,500/uL, and platelets ≥ 100,000/uL ii. Liver function: total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN) (if patients with liver metastasis, ≤ 5 times the ULN) iii. Renal function: Serum creatinine ≤ 1.5 times the ULN or creatinine clearance according to the Cockroft-Gault equation ≥ 60 ml/min
- •No possibility of pregnancy if the participant is female (over 60 years of age, without menstruation for more than one year, or underwent hysterectomy or bilateral oophorectomy). If there is a possibility of pregnancy, pregnancy test should be conducted prior to participation in the study to prove that it is not pregnancy
- •Patients who agree to use effective means of contraception during the trial and up to 8 weeks after final administration
- •Patients with the ability to understand the study and who are willing to sign a written informed consent document
排除标准
- •Patients undergoing any systemic therapy or regional therapy including radiotherapy, for the purpose of treating cancer
- •Participants with known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, Trichosanthes Kirilowii Maximowicz, and polysorbate 80
- •Patients with active infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis)
- •Patients with history of human immunodeficiency virus infection
- •Patients with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, hypertension that remains uncontrolled: 140/90 mm Hg or higher)
- •Patients with active cytomegalovirus infection within the past 4 weeks
- •Patients who have experienced major surgery on cerebrovascular disease such as acute coronary syndrome, stroke, etc., within the past year
- •pregnant or lactating females
- •Patient with metastatic encephalopathy with symptoms
- •Patients who have donated blood or participated in other clinical trials of medicine or medical devices within the past month
- •Patient underwent organ transplantation including allogenic stem cell transplantation
- •Patients with complications of infectious diseases
- •Patients with suspected fever caused by infection
- •Patients with substance abuse or any neurological, medical, psychological, or sociological conditions that could potentially interfere with their compliance to the study protocol or interpretation of study results
- •Patients who are judged inappropriate for the study by investigator
- •Patients who are judged to have lost their ability to consent due to accompanying disease such as dementia
研究组 & 干预措施
Experimental group
干预措施: Combination of SH003 and Docetaxel (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: up to 4 weeks
adverse event according to CTCAE
次要结局
未报告次要终点
研究者
Seong-Gyu Ko
Prof.
Kyunghee University Medical Center