A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Solid Tumor, Adult Clinical Trial

Official title:

A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081819
• Other study ID #: ISEE_2015_SH003
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2017
• Est. completion date: July 25, 2019

Study information

• Verified date: September 2019
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 25, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Drug:
• SH003
Herbal medicine for cancer treatment

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Grade 3-4 adverse event using CTCAE v4.03	3 weeks