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| ID | Type | Description | Link |
|---|---|---|---|
| UTN U1111-1294-4392 | Other Identifier | WHO |
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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:
Participants will receive pitavastatin in differing dosages a week before their elective surgery and blood and tumour samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose group 1: 16 mg | Experimental | Pitavastatin 16 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
|
| Dose group 2: 32 mg | Experimental | Pitavastatin 32 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
|
| Dose group 3: 48 mg | Experimental | Pitavastatin 48 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin calcium | Drug | Daily Pitavastatin administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue. | Detection of pitavastatin in gadolinium enhanced and gadolinium non-enhanced tumour. tissue in relation to serum levels after preoperative administration. | From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of short-term pitavastatin treatment as assesseb by a customized questionnaire related to adverse events found during the use of pitavastatin. | Number of AEs, SAEs and SUSARs collected at the end of the trial. Events will be scored according to CTC criteria version 5.0 (Published November 27th, 2017). | From the last patient visit of the last dose cohort to 2 weeks after the last patient visit of the last dose cohort on day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in RNA expression after pitavastatin exposure in tumour tissue using RNA sequencing. | Using RNA sequencing on collected tumour samples from the gadolinium enhanced part of the tumour. | From the last tumour tissue acquisition of the last patient of the last dose cohort to 3 months after all tissue is collected. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Dirven, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | 3015 GE | Netherlands |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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open label, dose-finding, 3+3-like dose-escalation study design
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| Relation of plasma pitavastatin concentration and intratumoral pitavastatin concentration as assessed by LC-MS analysis on plasma and tumour tissue. | Correlation of pitavastatin concentration in plasma to pitavastatin concentration in different tumour sites(gadolinium enhanced, gadolinium non-enhanced and tumour periphery). | From the moment the LC-MS analysis of the last patient tumour tissue and plasma is performed to two weeks after the last patient visit on day 9 of the last dose cohort. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |