Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin
NCT05977738 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-08-07
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
- DRUG
-
Pitavastatin calcium
Daily Pitavastatin administration
Sponsors & Collaborators
-
C.Dirven
lead OTHER
Principal Investigators
-
Clemens Dirven, MD, PhD · Erasmus Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-18
- Primary Completion
- 2024-07-19
- Completion
- 2024-07-19
Countries
- Netherlands
Study Locations
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