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

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd1 site in 1 country26 target enrollmentApril 12, 2016

ConditionsGlioblastoma

InterventionsChlorogenic acid

DrugsChlorogenic acid

Overview

Phase: Phase 1
Intervention: Chlorogenic acid
Conditions: Glioblastoma
Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Enrollment: 26
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0，grade ≥3 (DLT)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 ;

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.

Registry

clinicaltrials.gov

Start Date

April 12, 2016

End Date

September 13, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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:
•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

•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；

Arms & Interventions

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%.

Intervention: Chlorogenic acid

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0，grade ≥3 (DLT)