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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Kyunghee University Medical Center
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center Identifier:
First received: March 10, 2017
Last updated: NA
Last verified: March 2017
History: No changes posted

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.

Condition Intervention Phase
Solid Tumor, Adult
Drug: SH003
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: No masking
Primary Purpose: Other
Official Title: A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 3 weeks ]
    Grade 3-4 adverse event using CTCAE v4.03

Estimated Enrollment: 18
Anticipated Study Start Date: March 20, 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SH003
Participant will take SH003 for 3 weeks.
Drug: SH003
Herbal medicine for cancer treatment


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT03081819

Contact: Chunhoo Cheon, Doctor 82-2-961-9278

Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 16499
Contact: EUNJIN KWON    +82-31-219-6324      
Sponsors and Collaborators
Kyunghee University Medical Center
  More Information

Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center Identifier: NCT03081819     History of Changes
Other Study ID Numbers: ISEE_2015_SH003
Study First Received: March 10, 2017
Last Updated: March 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No processed this record on May 22, 2017