Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
NCT02245204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2018-11-21
Summary
The purpose of this study:
Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced malignant tumor subjects;
Conditions
Interventions
- DRUG
-
Chlorogenic acid
Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
collaborator OTHER -
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
lead INDUSTRY
Principal Investigators
-
Lin Shen, Dr · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
Countries
- China
Study Locations
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