NCT05977738

Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin

Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: C.Dirven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase 0 trial is to study if pre-operative oral pitavastatin administration reaches the tumour in patients with primary or a recurrent glioblastoma. The main question\[s\] it aims to answer are: * Does pitavastatin reach a cytotoxic concentration in gadolinium-enhanced tumour tissue after oral administration? * Does pitavastatin achieve a concentration that can synergize with temozolomide in the gadolinium non-enhanced area of the tumour? Participants will receive pitavastatin in differing dosages a week before their elective surgery and blood and tumour samples will be collected.

Conditions

• Glioblastoma Multiforme, Adult
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Pitavastatin calcium	Daily Pitavastatin administration

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2023-08-04
• Last updated: 2024-08-07

Locations

1 site across 1 country: Netherlands