Solid Tumor, Adult
Conditions
Brief summary
A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer. The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The third dose group receives SH003 for 3 weeks.
Interventions
DRUGSH003
Herbal medicine for cancer treatment
Sponsors
Kyunghee University Medical Center
Study design
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years or older * Patients with histologically and cytologically confirmed solid tumor * Patients who have failed standard treatments, such as previous chemotherapy or radiotherapy, or who are inoperable, refractory, or progressive. * ECOG score 0-2 * Patients with a minimum life expectancy of 12 weeks at the scheduled starting date of the study drug * Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects. * Patients who can swallow pills. * Patients who provide written informed consent for participation in the trial
Exclusion criteria
* Known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, or Trichosanthes Kirilowii Maximowicz * Patients with pre-existing cardiac conditions: * Prior documented myocardial infarction within the last 6 months * Pre-existing cardiac failure (NYHA class III-IV) * Atrial fibrillation on anti-coagulants * Unstable angina * Severe valvulopathy * Cardiac angioplasty or stenting with in the last 6 months * Pregnant or lactating females * Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety * Active uncontrolled infection, including known history of AIDS or hepatitis B or C * Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol * Concurrently receiving any other investigational agents while on study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 weeks | Grade 3-4 adverse event using CTCAE v4.03 |
Countries
South Korea
Outcome results
None listed