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A Phase I Study of High Dose Simvastatin in Patients With Gastrointestinal Tract Cancer Who Failed to Standard Chemotherapy

NCT03086291 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-12-30

No results posted yet for this study

Summary

Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5 mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( ) mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3 weeks

Conditions

  • Stomach Cancer

Interventions

DRUG

Simvastatin

Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086291 on ClinicalTrials.gov