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

NCT03081819 | Completed Phase 1

• 1 other identifier: ISEE_2015_SH003
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Grade 3-4 adverse event using CTCAE v4.03

  3 weeks

Study Arms (1)

SH003

EXPERIMENTAL

Participant will take SH003 for 3 weeks.

Drug: SH003

Interventions

SH003 DRUG

Herbal medicine for cancer treatment

SH003

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Ajou University Hospital

Suwon, 16499, South Korea

Location

Related Publications (2)

• 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.

  PMID: 32186413 DERIVED

• 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.

  PMID: 30082340 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: March 29, 2017
• Primary Completion: April 16, 2019
• Study Completion: July 25, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)