Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer

Advanced Lung Cancer Clinical Trial

Official title:

A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751592
• Other study ID #: LYS-LC-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 17, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2018
• Source: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
• Contact: Sheng Yang, Dr
• Phone: 8613683260156
• Email: medart[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.

Description:

1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;

2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;

3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;

4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;

5. Determine Eastern Cooperative Oncology Group（ECOG）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18;

2. Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC;

3. Estimated lifetime = 3 months;

4. Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count=80×10~9/L; 2)NEUT# count=1.5×10~9/L ;3)HGB count=90g/L;4)Total bilirubin <=1.5 times of ULN;5)ALT/AST =2.5 times of ULN;

5. Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;

6. Volunteered for the phase 1 trial and sign the informed consent without protest.

Exclusion Criteria:

1. 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.;

2. Patients with brain metastases;

3. Patients with bone metastases;

4. Patients who have primary immunodeficiency;

5. Organ transplanters recipients;

6. Patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment;

7. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;

8. Patients who had received a therapy of another investigational drug within 1 month;

9. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;

10. Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment;

11. Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters;

12. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;

13. Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment;

14. History of drug abuse;

15. Patients who was treated with Immunologic drugs in 3 months;

16. Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease control rate(DCR)		Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary	objective response rate (ORR)		Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary	progress free survival(PFS)		Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary	Overall Survival(OS)		Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary	Eastern Cooperative Oncology Group (ECOG) score standard		Within the first 10 weeks after the first dose of chlorogenic acid for injection