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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.
Verified July 2017 by Seong-Gyu Ko, Kyunghee University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03081819
First Posted: March 16, 2017
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center
  Purpose

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: None (Open Label)
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 Seong-Gyu Ko, 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
Actual Study Start Date: March 30, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081819


Contacts
Contact: Chunhoo Cheon, Doctor 82-2-961-9278 hreedom35@gmail.com

Locations
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
ClinicalTrials.gov Identifier: NCT03081819     History of Changes
Other Study ID Numbers: ISEE_2015_SH003
First Submitted: March 10, 2017
First Posted: March 16, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No