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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: SH003

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SH003; Participant will take SH003 for 3 weeks.	Drug: SH003; Herbal medicine for cancer treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Grade 3-4 adverse event using CTCAE v4.03	3 weeks

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2017
• Primary Completion (ACTUAL): April 16, 2019
• Study Completion (ACTUAL): July 25, 2019

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (ACTUAL): March 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ISEE_2015_SH003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No