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

Phase 1

• Conditions: Advanced Lung Cancer
• Interventions: Drug: Chlorogenic acid

• Registration Number: NCT03751592
• Lead Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Brief 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.

Detailed 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）.

Study Timeline

• Study Start: 2018-07-17
• Status Verified: 2018-09
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-26
• Primary Completion: 2020-10-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorogenic acid, Treatment, powder	Chlorogenic acid	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%.

Primary Outcome Measures

Name	Time	Method
disease control rate（DCR)	Within the first 10 weeks after the first dose of chlorogenic acid for injection

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	Within the first 10 weeks after the first dose of chlorogenic acid for injection
progress free survival(PFS)	Within the first 10 weeks after the first dose of chlorogenic acid for injection
Overall Survival（OS）	Within the first 10 weeks after the first dose of chlorogenic acid for injection
Eastern Cooperative Oncology Group （ECOG） score standard	Within the first 10 weeks after the first dose of chlorogenic acid for injection

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China