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Clinical Trials/NCT02136342
NCT02136342TerminatedPhase 1

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

Chinese Academy of Medical Sciences0 sitesStarted: May 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Primary Endpoint
Number of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

chlorogenic acid

Experimental

Intervention: chlorogenic acid (Drug)

Outcomes

Primary Outcomes

Number of adverse events

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shi Yuankai

Dr.

Chinese Academy of Medical Sciences

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