drugset / Trial / NCT03086291
A Phase I Study of High Dose Simvastatin in Patients With Gastrointestinal Tract Cancer Who Failed to Standard Chemotherapy
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2018-01-04
- Primary completion
- 2020-09
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 7.5 mg/kg | — |
| Subject | Simvastatin | Small molecule | 10 mg/kg | — |