Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Eligible for resection of a suspected primary glioblastoma or a recurrent glioblastoma. 2. MRI- measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 1 perpendicular measurement of at least 0.5 cm. 3. Adequate Renal Function defined as: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation. 4. CK elevation 3 X ULN. 5. Ability to understand and the willingness to sign a written informed consent document. 6. 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. 7. Willingness and ability to comply with all scheduled visits, treatment plans, laboratory tests and other procedures. 8. Age ≥18 years at time of consent. 9. Ability and willingness to swallow oral medication. 10. 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. 11. 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. 12. Females of child-bearing potential must agree not to breastfeed starting at screening, and throughout the study period.

Exclusion Criteria:

1. Pregnancy or lactation. 2. Known allergic reactions to components of the pitavastatin calcium tablets. 3. Patients with ALAT and ASAT levels 3 X ULN. 4. Unwillingness to temporarily stop an already prescribed statin, during treatment with pitavastatin. 5. Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy. 6. Concomitant use of cyclosporin, gemfibrozil, systemic fusidic acid, fibrates, niacin or colchicine. 7. 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. 8. Suspicion of oral malabsorption, influencing the uptake of drugs from the ileum, such as Morbus Crohn. 9. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05977738
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

C.Dirven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clemens Dirven, MD, PhD
Principal Investigator Affiliation Erasmus Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, Adult, Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: Dose group 1: 16 mg

Pitavastatin 16 mg via oral route in the form of daily tablets for 6 days before SOC surgery

Experimental: Dose group 2: 32 mg

Pitavastatin 32 mg via oral route in the form of daily tablets for 6 days before SOC surgery

Experimental: Dose group 3: 48 mg

Pitavastatin 48 mg via oral route in the form of daily tablets for 6 days before SOC surgery

Interventions

Drug: - Pitavastatin calcium

Daily Pitavastatin administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Erasmus MC, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, , 3015 GE

Site Contact

Puspha Achaiber Sing, MSc

[email protected]

+31107035993

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