Phase I study of SH003
- Conditions
- Neoplasms
- Registration Number
- KCT0007878
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 18
age 19 years and older
- histologically or cytologically confirmed solid cancers for which standard curative measures do not exist or are no longer effective
- Eastern Cooperative Oncology Group (ECOG) Performance Status =2
- estimated life expectancy of at least 12 weeks
- no chemotherapy or surgery within the last 4 weeks
- recovery levels of hemoglobin at =8 g/dL, platelet count =100,000/µL, and absolute neutrophil count =1,500/µL, bilirubin = 2.5 times the upper limit of normal, AST/ALT = 2.5 times the upper limit of normal, serum creatinine = 1.5 times the upper limit of normal or calculated CCr = 60mL/min
- Not pregnant or consenting to birth control
- the ability to swallow tablets
- the ability to understand the study
- willingness to sign a written informed consent document
- known hypersensitivity to any study drug component, including A. membranaceus, A. gigas, and T. kirilowii
- with acute or chronic infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis)
- with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, or uncontrolled hypertension of 140/90 mm Hg or higher)
- with active cytomegalovirus infection within the past 4 weeks
- with a history of major surgery for cerebrovascular disease such as acute coronary syndrome, stroke, etc., within the past year
- pregnant or lactating women and those with childbearing potential
- patients with any psychological, sociological, or geographical conditions that could potentially interfere with their compliance with the study protocol
- patients who had participated in other clinical trials of medicine or medical devices within the past month.
- patients underwent organ transplantation, including allogeneic stem cell transplantation
- patients judged to have lost the ability to consent due to accompanying diseases such as dementia
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxocity
- Secondary Outcome Measures
Name Time Method Tumor response