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 ;
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Beijing Shijitan Hospital,Capital Medical University
Beijing, China
Number of adverse events
Time frame: Within the first 30 days after the first dose of chlorogenic acid
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0,grade ≥3 (DLT)
Time frame: Within the first 30 days after the first dose of chlorogenic acid
Maximum Tolerated Dose
Time frame: Within the first 30 days after the first dose of chlorogenic acid
Area under the plasma concentration versus time curve (AUC) of chlorogenic acid
Time frame: Within the first 30 days after the first dose of chlorogenic acid
Peak Plasma Concentration (Cmax) of chlorogenic acid
Time frame: Within the first 30 days after the first dose of chlorogenic acid
Improvement in cancer-related symptoms
Time frame: Within 1 year after the first dose of chlorogenic acid
disease control rate(DCR)
Time frame: Within the first 30 days after the first dose of chlorogenic acid
objective response rate (ORR)
Time frame: Within the first 30 days after the first dose of chlorogenic acid
progress free survival(PFS)
Time frame: Within the first 30 days after the first dose of chlorogenic acid
overall survival (OS)
Time frame: Within the first 30 days after the first dose of chlorogenic acid
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Improvement in quality of life
Time frame: Within 1 year after the first dose of chlorogenic acid