NCT04512105 is a Phase 1 clinical trial of Pitavastatin in Acute Myeloid Leukemia, sponsored by University of California, Irvine.

Who is sponsoring NCT04512105?

NCT04512105 is sponsored by University of California, Irvine.

What drugs are being tested in NCT04512105?

Interventions in NCT04512105: Pitavastatin, Venetoclax.

What condition does NCT04512105 study?

NCT04512105 studies Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, AML, Adult, CLL, CLL, Relapsed, CLL, Refractory.

Is NCT04512105 still recruiting?

NCT04512105 is currently completed. Last updated 11 September 2025.

Last reviewed 2025-09-11 · How we verify

NCT04512105

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 11 September 2025

What this trial tests

Phase 1 trial testing Pitavastatin in Acute Myeloid Leukemia in 6 participants. Completed in 5 February 2025.

Timeline

2 December 2020

Primary endpoint
20 July 2024

5 February 2025

Quick facts

Lead sponsor	University of California, Irvine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	2 December 2020
Primary completion	20 July 2024
Estimated completion	5 February 2025
Sites	1 location across United States

Drugs / interventions tested

Pitavastatin (PITAVASTATIN) — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
AML, Adult — all drugs for AML, Adult →
CLL — all drugs for CLL →

Sponsor

University of California, Irvine

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting the Mevalonate Pathway in Cancer.
Juarez D, Fruman DA. · · 2021 · cited 127× · PMID 33358111 · DOI 10.1016/j.trecan.2020.11.008
Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006
Role of mitochondria in physiological activities, diseases, and therapy.
Wang L, Zhou X, Lu T. · · 2025 · cited 23× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5
Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.
El-Cheikh J, Bidaoui G, Saleh M, Moukalled N, et al · · 2023 · cited 22× · PMID 37071328 · DOI 10.1007/s44228-023-00041-x
How We Incorporate Venetoclax in Treatment Regimens for Acute Myeloid Leukemia.
Maiti A, Konopleva MY. · · 2022 · cited 19× · PMID 35072368 · DOI 10.1097/ppo.0000000000000567
Mutant p53, the Mevalonate Pathway and the Tumor Microenvironment Regulate Tumor Response to Statin Therapy.
Pereira M, Matuszewska K, Glogova A, Petrik J. · · 2022 · cited 17× · PMID 35884561 · DOI 10.3390/cancers14143500
Tipping the balance: toward rational combination therapies to overcome venetoclax resistance in mantle cell lymphoma.
Thus YJ, Eldering E, Kater AP, Spaargaren M. · · 2022 · cited 17× · PMID 35725771 · DOI 10.1038/s41375-022-01627-9
Functional Drug Screening in the Era of Precision Medicine.
Napoli GC, Figg WD, Chau CH. · · 2022 · cited 16× · PMID 35879922 · DOI 10.3389/fmed.2022.912641

Verify or expand the search:

Other trials of Pitavastatin

Trials testing the same drug.

NCT06982131 — A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Ros · Phase 1 · recruiting
NCT06813924 — A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants · Phase 1 · completed
NCT05537948 — Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients · Phase 4 · active not recruiting
NCT04705909 — Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer · Phase 2, PHASE3 · unknown
NCT04643093 — Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia · Phase 3 · completed

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other University of California, Irvine trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04512105 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Irvine
Last refreshed: 11 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04512105.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing