Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin

NCT ID: NCT05977738

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-07-19

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dose group 1: 16 mg

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

Group Type: EXPERIMENTAL

Pitavastatin calcium

Intervention Type: DRUG

Daily Pitavastatin administration

Dose group 2: 32 mg

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

Group Type: EXPERIMENTAL

Pitavastatin calcium

Intervention Type: DRUG

Daily Pitavastatin administration

Dose group 3: 48 mg

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

Group Type: EXPERIMENTAL

Pitavastatin calcium

Intervention Type: DRUG

Daily Pitavastatin administration

Interventions

Pitavastatin calcium

Daily Pitavastatin administration

Intervention Type: DRUG

Other Intervention Names

Alipza

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C.Dirven

OTHER

Sponsor Role: lead

Responsible Party

C.Dirven

Prof. dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Clemens Dirven, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

UTN U1111-1294-4392

Identifier Type: OTHER

Identifier Source: secondary_id

2023-505743-38-00

Identifier Type: -

Identifier Source: org_study_id