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OpenTrials
Completed

NCT Number: NCT03081819

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ajou University Hospital

Suwon, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SH003

Drug

Herbal medicine for cancer treatment

Primary outcomes

  1. Adverse events

    Time frame: 3 weeks

    Grade 3-4 adverse event using CTCAE v4.03

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2017
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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