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

Kyung Hee University

Status and phase: Completed; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: SH003

Study type: Interventional

Funder types: Other

Identifiers

NCT03081819

ISEE_2015_SH003

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

SH003

Experimental group

Description:

Participant will take SH003 for 3 weeks.

Treatment:

Drug: SH003