NCT02136342

Brief Summary

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

May 9, 2014

Last Update Submit

October 19, 2014

Conditions

Advanced Cancer

Keywords

no available effective treatment

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    within the first 60 days after the first dose of chlorogenic acid

Secondary Outcomes (4)

  • 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

  • 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

Other Outcomes (3)

  • Change in number of red blood cell and level of hemoglobin

    within 1 year after the first dose of chlorogenic acid

  • change in the diameters of lymph node metastasis

    within 1 year after the first dose of chlorogenic acid

  • change in levels of tumor markers

    within 1 year after the first dose of chlorogenic acid

Study Arms (1)

chlorogenic acid

EXPERIMENTAL
Drug: chlorogenic acid

Interventions

chlorogenic acidDRUG
chlorogenic acid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Chlorogenic Acid

Intervention Hierarchy (Ancestors)

CinnamatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCyclohexanecarboxylic Acids

Study Officials

  • Yuankai Shi, Dr.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Last Updated

October 21, 2014

Record last verified: 2014-10