NCT03086291

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase 1, open-label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of high dose simvastatin in patients with GI cancers. Three dose levels will be evaluated. Simvastatin will be given at escalating dose of 7.5mg/kg bid, 10mg/kg bid and ( ) mg/kg bid for 7 days and off treatment for 14 days (Final dose will be determined based on PK data of cohort 1 and 2). The treatment will be repeated every 3 weeks. The cohort size of at least 3 and up to 6 patients ('rolling six design') will be employed to improve the rate of accrual of patients to cohorts close to the presumed therapeutic dose by reducing the need for late replacement of patients who become non-evaluable during the DLT assessment period, whilst not compromising collection of safety data. The total number of patients will depend upon the number of dose adjustments necessary. And intra-patient dose escalation is not allowed.

Conditions

• Stomach Cancer

Interventions

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

Timeline

• Start date: 2018-01-04
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2017-03-22
• Last updated: 2019-12-30

Locations

1 site across 1 country: South Korea