Clinical trial NCT03081819: A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer
Official title: A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
citation: Cheon C, Ko SG. A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420911442. doi: 10.1177/1534735420911442.
citation: Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol. BMJ Open. 2018 Aug 5;8(8):e019502. doi: 10.1136/bmjopen-2017-019502.