Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

NCT02728349 | Completed Phase 1

• 1 other identifier: LYS-I-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 ;

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (5)

• Number of adverse events

  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)

  Within the first 30 days after the first dose of chlorogenic acid

• Maximum Tolerated Dose

  Within the first 30 days after the first dose of chlorogenic acid

• Area under the plasma concentration versus time curve (AUC) of chlorogenic acid

  Within the first 30 days after the first dose of chlorogenic acid

• Peak Plasma Concentration (Cmax) of chlorogenic acid

  Within the first 30 days after the first dose of chlorogenic acid

Secondary Outcomes (6)

• Improvement in cancer-related symptoms

  Within 1 year after the first dose of chlorogenic acid

• disease control rate(DCR)

  Within the first 30 days after the first dose of chlorogenic acid

• objective response rate (ORR)

  Within the first 30 days after the first dose of chlorogenic acid

• progress free survival(PFS)

  Within the first 30 days after the first dose of chlorogenic acid

• overall survival (OS)

  Within the first 30 days after the first dose of chlorogenic acid

Other Outcomes (4)

• Changing in number of red blood cell

  Within 1 year after the first dose of chlorogenic acid

• Changing in cytokines in peripheral blood

  Within 1 year after the first dose of chlorogenic acid

• Changing in level of hemoglobin

  Within 1 year after the first dose of chlorogenic acid

Study Arms (1)

Chlorgenic acid, Treatment, powder

EXPERIMENTAL

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

Chlorogenic acid DRUG

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.

Chlorgenic acid, Treatment, powder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• )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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd: lead
• Beijing Shijitan Hospital, Capital Medical University: collaborator

Study Sites (1)

Beijing Shijitan Hospital,Capital Medical University

Beijing, 100038, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Chlorogenic Acid

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cinnamates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanecarboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 5, 2016
• Study Start: April 12, 2016
• Primary Completion: August 23, 2017
• Study Completion: September 13, 2017
• Last Updated: November 1, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)