CompletedNCT02728349Updated Nov 1, 2018

Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

A Phase 1 interventional study of Chlorogenic acid in Glioblastoma, sponsored by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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 ;

Read the detailed description

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 ;
Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;
Preliminary observation the effectiveness and effective dose;
Provide the basis for the dosage regimen of phase II/III.

Conditions studied

Glioblastoma

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Glioblastoma 1,920

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 26 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

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Lead sponsor

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with pathologic or/and FNAC confirmation of advanced glioblastoma(WHO,III-IV grade) but without effective treatment or with treatment failure;
Between 18 and 65 years of age, KPS≥40;
According to RANO(2010), the parents will be eligible if one of the following conditions apply: steroid dose increased or stable,the enhanced tumor lesion increased more than 25%; the unenhanced tumor lesion increased because of the progressive tumor,even if the lesion was unmeasurable.
Life expectancy of at least three (3) months at the enrollment;
Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:

1)PLT count≥100×10\~9/L, 2)WLB count≥4.0×10\~9/L and ≤12×10\~9/L, 3)Neutrophil granulocyte count≥2.0×10\~9/L, 4)HGB count≥90g/L, 5)Total bilirubin \<=1.5 times of ULN, 6)ALT/AST ≤2.5 times of ULN, 7)SCr≤1.5 times of ULN, 8)Normal ECG with LVEF (≥50%) measured by echocardiography; 6.Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months; 7.Volunteered for the phase 1 trial and sign the informed consent without protest;

Exclusion criteria

Exclusion Criteria:

Patients who have received large area radiotherapy （>30% marrow capacity）;
Without pathologic or/and FNAC confirmation of advanced glioblastoma;
Patients who has primary immunodeficiency diseases；
Patients who suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.;
Patients who have received the therapy of chemotherapy or radical radiotherapy within 4 weeks before enrollment;
Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;
Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 2 weeks before enrollment;
Patients who experience grade 2 or more than grade 2 toxicity caused by the past therapies;
Patients who have history of drug abuse;
Uncontrollable psychopaths；
Uncontrollable diabetes；
Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
Patients who had received a therapy of another investigational drug within 12 weeks or patients who are still in another clinical trial at the enrollment;
Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters;
Allergic to the investigational drug;
Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
Patients who have received the therapy of adrenal steroid hormones within 1 week before enrollment or will receive the therapy for a long period time，except for Corticosteroid nasal spray，Inhaled Steroid and Topical steroids .

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Experimental
Chlorgenic acid, Treatment, powder
Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
Drug: Chlorogenic acid

Interventions

DrugChlorogenic 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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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
Improvement in quality of life
Time frame: Within 1 year after the first dose of chlorogenic acid

Other outcomes

Changing in number of red blood cell
Time frame: Within 1 year after the first dose of chlorogenic acid
Changing in cytokines in peripheral blood
Time frame: Within 1 year after the first dose of chlorogenic acid
Changing in level of hemoglobin
Time frame: Within 1 year after the first dose of chlorogenic acid
Changing in lymphocyte subsets
Time frame: Within 1 year after the first dose of chlorogenic acid

Study locations

1 site

Beijing Shijitan Hospital,Capital Medical University
Beijing, 100038, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02728349
Lead sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Collaborators: Beijing Shijitan Hospital, Capital Medical University
Responsible party: Sponsor
First posted: Apr 5, 2016
Start date: Apr 12, 2016
Primary completion: Aug 23, 2017
Completion: Sep 13, 2017
Last update: Nov 1, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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