NCT03751592UnknownPhase 1
A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd1 site in 1 country144 target enrollmentStarted: July 17, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- disease control rate（DCR)
Study Overview
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
- Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine Eastern Cooperative Oncology Group（ECOG）.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC;
- •Estimated lifetime ≥ 3 months；
- •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；
- •Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
- •Volunteered for the phase 1 trial and sign the informed consent without protest.
Exclusion Criteria
- •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 with brain metastases;
- •Patients with bone metastases;
- •Patients who have primary immunodeficiency;
- •Organ transplanters recipients;
- •Patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment;
- •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 1 month；
- •Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
- •Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment;
- •Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；
- •Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;
- •Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment;
- •History of drug abuse；
- •Patients who was treated with Immunologic drugs in 3 months;
- •Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
Arms & Interventions
Chlorogenic 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%.
Intervention: Chlorogenic acid (Drug)
Outcomes
Primary Outcomes
disease control rate（DCR)
Time Frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
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