NCT02728349

Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

Phase 1 Trial of Tolerance and Pharmacokinetic of Chlorogenic Acid for Injection in the Advanced Glioblastoma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 Glioblastoma Patients ;

Detailed description

1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced Glioblastoma Patients ; 2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection; 3. Preliminary observation the effectiveness and effective dose; 4. Provide the basis for the dosage regimen of phase II/III.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-12
• Primary completion: 2017-08-23
• Completion: 2017-09-13
• First posted: 2016-04-05
• Last updated: 2018-11-01

Locations

1 site across 1 country: China