Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

October 19, 2014 updated by: Shi Yuankai, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: chlorogenic acid
Drug: chlorogenic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: within the first 60 days after the first dose of chlorogenic acid
within the first 60 days after the first dose of chlorogenic acid

Secondary Outcome Measures

Outcome Measure
Time Frame
dose-limiting toxicity
Time Frame: within the first 30 days after the first dose of chlorogenic acid
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
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
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
within 1 year after the first dose of chlorogenic acid

Other Outcome Measures

Outcome Measure
Time Frame
Change in number of red blood cell and level of hemoglobin
Time Frame: within 1 year after the first dose of chlorogenic acid
within 1 year after the first dose of chlorogenic acid
change in the diameters of lymph node metastasis
Time Frame: within 1 year after the first dose of chlorogenic acid
within 1 year after the first dose of chlorogenic acid
change in levels of tumor markers
Time Frame: within 1 year after the first dose of chlorogenic acid
within 1 year after the first dose of chlorogenic acid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (ESTIMATE)

May 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 19, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYS-I-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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