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

NCT ID: NCT03081819

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2019-07-25

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

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SH003

Participant will take SH003 for 3 weeks.

Group Type: EXPERIMENTAL

SH003

Intervention Type: DRUG

Herbal medicine for cancer treatment

Interventions

SH003

Herbal medicine for cancer treatment

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyunghee University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seong-Gyu Ko

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 32186413 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30082340 (View on PubMed)

Other Identifiers

ISEE_2015_SH003

Identifier Type: -

Identifier Source: org_study_id