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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02136342
Other study ID # LYS-I-01
Secondary ID
Status Terminated
Phase Phase 1
First received May 9, 2014
Last updated October 19, 2014
Start date May 2014

Study information

Verified date October 2014
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- advanced cancer with no effective treatment

- Karnofsky performance status no less than 70

- adequated organ function

- informed consent

Exclusion Criteria:

- allergic to chlorogenic acid

- persistent toxicities from previous treatment (no less than grade 2)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
chlorogenic acid


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Outcome

Type Measure Description Time frame Safety issue
Other Change in number of red blood cell and level of hemoglobin within 1 year after the first dose of chlorogenic acid No
Other change in the diameters of lymph node metastasis within 1 year after the first dose of chlorogenic acid No
Other change in levels of tumor markers within 1 year after the first dose of chlorogenic acid No
Primary Number of adverse events within the first 60 days after the first dose of chlorogenic acid Yes
Secondary dose-limiting toxicity within the first 30 days after the first dose of chlorogenic acid Yes
Secondary maximum tolerated dose within the first 30 days after the first dose of chlorogenic acid Yes
Secondary Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid within the first 30 days after the first dose of chlorogenic acid No
Secondary improvement in cancer-related symptoms and quality of life within 1 year after the first dose of chlorogenic acid No
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