Glioblastoma Multiforme, AdultEarly Phase 1ReDiReCCT-PitaNCT05977738
Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin
A Early Phase 1 study testing Pitavastatin calcium in people with Glioblastoma Multiforme, Adult and Recurrent Glioblastoma, run by C.Dirven at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Adult, Recurrent Glioblastoma
- What is being tested?
- Pitavastatin calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2024to 19 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for resection of a suspected primary glioblastoma or a recurrent glioblastoma.
- MRI- measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 1 perpendicular measurement of at least 0.5 cm.
- Adequate Renal Function defined as: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation.
- CK elevation 3 X ULN.
- Ability to understand and the willingness to sign a written informed consent document.
- Participant has voluntarily agreed to participate by giving written informed consent Written informed consent for participation in the protocol must be obtained prior to any screening procedures taking place.
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- Willingness and ability to comply with all scheduled visits, treatment plans, laboratory tests and other procedures.
- Age ≥18 years at time of consent.
- Ability and willingness to swallow oral medication.
- Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
- For females of reproductive potential: use of highly effective contraception method defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly.
- Females of child-bearing potential must agree not to breastfeed starting at screening, and throughout the study period.
Who cannot join
- Pregnancy or lactation.
- Known allergic reactions to components of the pitavastatin calcium tablets.
- Patients with ALAT and ASAT levels 3 X ULN.
- Unwillingness to temporarily stop an already prescribed statin, during treatment with pitavastatin.
- Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy.
- Concomitant use of cyclosporin, gemfibrozil, systemic fusidic acid, fibrates, niacin or colchicine.
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- Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, unexplained elevated liver transaminase levels, and active and chronic hepatitis as determined by the investigator.
- Suspicion of oral malabsorption, influencing the uptake of drugs from the ileum, such as Morbus Crohn.
- Treatment with another investigational drug or other intervention within 30 days prior to enrolment or within 5 half-lives of the investigational product, whichever is longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients
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.
- Being tested
- Pitavastatin calcium
- Keywords
- Phase 0, GBM, Glioma, Pitavastatin
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin calciumDrug
Also called Alipza
Daily Pitavastatin administration
| Study group | Role | What they receive |
|---|---|---|
| Dose group 1: 16 mg | Experimental | Pitavastatin 16 mg via oral route in the form of daily tablets for 6 days before SOC surgery Receives: Drug: Pitavastatin calcium |
| Dose group 2: 32 mg | Experimental | Pitavastatin 32 mg via oral route in the form of daily tablets for 6 days before SOC surgery Receives: Drug: Pitavastatin calcium |
| Dose group 3: 48 mg | Experimental | Pitavastatin 48 mg via oral route in the form of daily tablets for 6 days before SOC surgery Receives: Drug: Pitavastatin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort.
Secondary outcomes (2)
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).
Measured: 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.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start18 Jan 2024
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- open label, dose-finding, 3+3-like dose-escalation study design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.Dirven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, C.Dirven, Erasmus Medical Center
- Investigators
- Clemens Dirven, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977738
- Sponsor's protocol ID
- 2023-505743-38-00
- Other IDs
- UTN U1111-1294-4392, 2023
- Acronym
- ReDiReCCT-Pita
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT05977738
- Acronym / sponsor ID
- ReDiReCCT-Pita / 2023-505743-38-00
- Keywords
- Phase 0, GBM, Glioma, Pitavastatin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- C.DirvenUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- open label, dose-finding, 3+3-like dose-escalation study design
| Arm | Type | Receives |
|---|---|---|
| Dose group 1: 16 mg | Experimental | Drug: Pitavastatin calciumPitavastatin 16 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
| Dose group 2: 32 mg | Experimental | Drug: Pitavastatin calciumPitavastatin 32 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
| Dose group 3: 48 mg | Experimental | Drug: Pitavastatin calciumPitavastatin 48 mg via oral route in the form of daily tablets for 6 days before SOC surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Eligible for resection of a suspected primary glioblastoma or a recurrent glioblastoma.
- MRI- measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 1 perpendicular measurement of at least 0.5 cm.
- Adequate Renal Function defined as: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation.
- CK elevation 3 X ULN.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Known allergic reactions to components of the pitavastatin calcium tablets.
- Patients with ALAT and ASAT levels 3 X ULN.
- Unwillingness to temporarily stop an already prescribed statin, during treatment with pitavastatin.
- Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin calciumAlso: AlipzaDaily Pitavastatin administration | Drug | Dose group 1: 16 mg, Dose group 2: 32 mg, Dose group 3: 48 mg |
Primary outcome
Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue.
Time frame: From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort.
Detection of pitavastatin in gadolinium enhanced and gadolinium non-enhanced tumour. tissue in relation to serum levels after preoperative administration.
2 secondary outcomes
Tolerability of short-term pitavastatin treatment as assesseb by a customized questionnaire related to adverse events found during the use of pitavastatin.
Time frame: 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.
Relation of plasma pitavastatin concentration and intratumoral pitavastatin concentration as assessed by LC-MS analysis on plasma and tumour tissue.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens Dirven, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pitavastatin calcium in people with Glioblastoma Multiforme, Adult and Recurrent Glioblastoma, run by C.Dirven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue. (time frame: From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.