cropped color_logo_with_background.png

Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

Study Purpose

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 ;

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with pathologic or/and FNAC confirmation of advanced glioblastoma(WHO,III-IV grade) but without effective treatment or with treatment failure; 2. Between 18 and 65 years of age, KPS≥40; 3. 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. 4. Life expectancy of at least three
  • (3) months at the enrollment; 5.
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:

1. Patients who have received large area radiotherapy (>30% marrow capacity); 2. Without pathologic or/and FNAC confirmation of advanced glioblastoma; 3. Patients who has primary immunodeficiency diseases; 4. 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.; 5. Patients who have received the therapy of chemotherapy or radical radiotherapy within 4 weeks before enrollment; 6. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment; 7. Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 2 weeks before enrollment; 8. Patients who experience grade 2 or more than grade 2 toxicity caused by the past therapies; 9. Patients who have history of drug abuse; 10. Uncontrollable psychopaths; 11. Uncontrollable diabetes; 12. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan; 13. 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; 14. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody; 15. Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters; 16. Allergic to the investigational drug; 17. Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator). 18. 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 .

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02728349
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Completed
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

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%.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Address

Beijing Shijitan Hospital,Capital Medical University

Beijing, , 100038