Symptoms and General Pathology

All Conditions

Neoplasms

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Recurrence

Glioblastoma

Glioma

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Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

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All Drugs and Chemicals

Bone Density Conservation Agents

Lipid Regulating Agents

Calcium

Calcium, Dietary

Pitavastatin

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Enzyme Inhibitors

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

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

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

Pitavastatin calcium

Puspha Achaiber Sing, MD, MSc

Judith Verhagen, PhD

Puspha Achaiber Sing, MSc

Clemens Dirven, MD, PhD

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.

open label, dose-finding, 3+3-like dose-escalation study design

Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin

Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients

Using RNA sequencing on collected tumour samples from the gadolinium enhanced part of the tumour.

Detection of pitavastatin in gadolinium enhanced and gadolinium non-enhanced tumour. tissue in relation to serum levels after preoperative administration.

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).

Correlation of pitavastatin concentration in plasma to pitavastatin concentration in different tumour sites(gadolinium enhanced, gadolinium non-enhanced and tumour periphery).

C.Dirven

Prof. dr.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Pitavastatin tablets 2 mg once daily.

For the intended neoadjuvant treatment period, participants will receive -in addition to standard chemotherapy protocol - Placebo tablets matching pitavastatin orally once daily.

Pitavastatin 2 mg oral tablets daily will be given to the patients concomitantly with the intended chemotherapy protocol for the treatment period prior to surgery.

patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.

placebo

Samar A Dewidar, bachelor

Omar H Abdelaleem, PHD

Amal M. Elgayar, professor

Amal M. Elgayar, Professor

Ahmed El tantawy, PHD

Moetaza M. Soliman, PHD

Different modalities for breast cancer treatments have exhausting and distressing side effects and toxicities leading to decreased compliance. Thus, repurposing drugs with accepted safety profile and possible antitumor activity becomes an eminent constraint.

Statins have been reported to have possible advantages as anticancer, and control of cancer progression. Moreover, they can sensitize cancer cells for radiotherapy. Therefore, the investigators aim to investigate the effect of (pitavastatin) added to conventional chemotherapy protocols for breast cancer patients.

Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50% decrease in the size of the primary tumor without appearance of new lesions.

It will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals.

Mansoura University

Lecturer of Surgical oncology, Principal Investigator, Surgery department.

Blood and Lymph Conditions

Immune System Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloid Leukemia

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Acute Non Lymphoblastic Leukemia

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Venetoclax

Azacitidine

Decitabine

Patients receive Pitavastatin (PIT) 1 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine.

The 1 mg/day dose level will be held in reserve to allow dose reduction in those patients who cannot tolerate DL1.

Patients receive Pitavastatin (PIT) 2 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine.

This is the starting dose level for the study.

Patients receive Pitavastatin (PIT) 4 mg PO daily. For CLL patients, they will also receive stabilized Venetoclax (VEN) 400mg PO daily. For AML patients, they will VEN mg PO daily when dosing in combination with azacitidine or decitabine.

If DL1 is well tolerated, the next cohort will progress to this dose level.

Elizabeth Brem, MD

This is a phase I, dose-escalation, open-label clinical trial determining the safety and tolerability of adding Pitavastatin to Venetoclax in subjects with chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML). These are subjects who are newly diagnosed subjects with AML who are ineligible for intensive induction chemotherapy, relapsed/refractory CLL or newly diagnosed CLL.

Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia

A Phase 1 Open-Label, Dose Escalation Study of Pitavastatin in Combination With Venetoclax in Patients With Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia

Change in PK parameters from baseline to Cycle 1 to determine if concomitant administration of PIT affects concentrations of VEN when given in combination with PIT.

BH3 profiling on pretreatment and post-treatment bloods samples to assess whether add on treatment with PIT increases apoptotic priming. In dynamic BH3 profiling, the degree of mitochondrial outer membrane permeabilization (MOMP) after exposure to drug is compared to the untreated baseline to quantify the change in priming or induced by exposure to a drug.

Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding to PIT to treatment with stable doses of VEN ± anti-CD20 antibodies (patients with CLL) or VEN with hypomethylating agents (patients with AML).

Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding to PIT to treatment with stable doses of VEN ± anti-CD20 antibodies (patients with CLL) or VEN with hypomethylating agents (patients with AML).

To evaluate the safety and tolerability of administering PIT in combination with VEN-containing SOC in patients with AML or CLL .

To evaluate the adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Primary efficacy endpoint is the complete response rate of subjects who receive PIT when given with VEN-containing SOC regimens. The 2018 International Working Group for Chronic Lymphocytic Leukemia (iwCLL) and 2017 European LeukemiaNet (ELN) definitions of Complete Response (CR) will be utilized to determine the CR rate.

Secondary efficacy endpoints are the rates for the other response categories of subjects who receive PIT when given with VEN-containing SOC regimens. The 2018 International Working Group for Chronic Lymphocytic Leukemia (iwCLL) and 2017 European LeukemiaNet (ELN) definitions of Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) will be utilized to determine the rates for each of these categories.

Responders are defined as individuals who either received a CR or PR. Responders = CR+PR.

Changes in safety status, such as Eastern Cooperative Oncology Group (ECOG), performance status, vital signs and laboratory assessments throughout treatment through the trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin	NCT05977738	Glioblastoma Mu... Recurrent Gliob...	Pitavastatin ca...	18 Years -	Erasmus Medical Center
Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer	NCT04705909	Breast Cancer	Pitavastatin placebo	18 Years -	Mansoura University
Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin	NCT05977738	Glioblastoma Mu... Recurrent Gliob...	Pitavastatin ca...	18 Years -	Erasmus Medical Center
Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin	NCT05977738	Glioblastoma Mu... Recurrent Gliob...	Pitavastatin ca...	18 Years -	Erasmus Medical Center
Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia	NCT04512105	Acute Myeloid L... Chronic Lymphoc... AML, Adult CLL CLL, Relapsed CLL, Refractory	Pitavastatin Venetoclax	18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for pitavastatin

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