Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

Phase 1

Terminated

• Conditions: Advanced Cancer
• Interventions: Drug: chlorogenic acid

• Registration Number: NCT02136342
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-13
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-19
• Last Update Posted: 2014-10-21
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• advanced cancer with no effective treatment
• Karnofsky performance status no less than 70
• adequated organ function
• informed consent

Exclusion Criteria

• allergic to chlorogenic acid
• persistent toxicities from previous treatment (no less than grade 2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chlorogenic acid	chlorogenic acid	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	within the first 60 days after the first dose of chlorogenic acid

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid	within the first 30 days after the first dose of chlorogenic acid
improvement in cancer-related symptoms and quality of life	within 1 year after the first dose of chlorogenic acid
dose-limiting toxicity	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