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

Phase 1

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Drug: SH003

• Registration Number: NCT03081819
• Lead Sponsor: Kyunghee University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2017-03-29
• Primary Completion: 2019-04-16
• Study Completion: 2019-07-25
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SH003	SH003	Participant will take SH003 for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Adverse events	3 weeks	Grade 3-4 adverse event using CTCAE v4.03

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of