Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

Phase 1TerminatedNCT02136342

Chinese Academy of Medical Sciences

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Advanced Cancer

Interventions

chlorogenic acidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of adverse events

Time frame: within the first 60 days after the first dose of chlorogenic acid

Secondary Outcomes

dose-limiting toxicity

Time frame: within the first 30 days after the first dose of chlorogenic acid

maximum tolerated dose

Time frame: within the first 30 days after the first dose of chlorogenic acid

Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid

Time frame: within the first 30 days after the first dose of chlorogenic acid

improvement in cancer-related symptoms and quality of life

Time frame: within 1 year after the first dose of chlorogenic acid

Data from ClinicalTrials.gov

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