ArticleBMC cancer2025
Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04024696 (An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care
Who cites it
3 citing papers in PubMed.
- Abexinostat, a histone deacetylases inhibitor, for patients with relapsed or refractory follicular lymphoma: a multi-center, single-arm phase 2 study.Signal transduction and targeted therapy · 2026Trial
- HDAC inhibitors as anticancer drugs: chemical diversity, clinical trials, challenges and perspectives.RSC advances · 2026Review
- Next-Generation HDAC Inhibitors: Advancing Zinc-Binding Group Design for Enhanced Cancer Therapy.Cells · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAbexinostat, an novel pan-histone deacetylase inhibitor, induces tumor apoptosis and demonstrates therapeutic potential in B cell non-Hodgkin lymphoma (NHL). This phase 1 study investigate the safety, pharmacokinetics (PK), and efficacy of abexinostat in Chinese patients with relapsed/refractory (r/r) B cell NHL.
methodsPatients with r/r B cell NHL received abexinostat orally at escalating doses of 40 mg twice daily (bis in die, BID), 60 mg BID, and 80 mg BID with a 4-h interval, for seven days followed by a 7-day drug-free interval. Patients took abexinostat once on 3 days before day 1 (D-3) of the first cycle in single dose period. If no dose limiting toxicity (DLT) occurred from D-3 to C1D1, the continuous dose period was started from C1D1, abexinostat was given BID. The Primary endpoints were safety and PK.
resultsFrom April 13, 2020 to November 30, 2023, 12 r/r B cell NHL patients were enrolled, including 6 follicular lymphoma (FL), 5 diffuse large B cell lymphoma (DLBCL) and 1 mantle cell lymphoma (MCL). 11 patients received at least one dose abexinostat included in the safety set. No DLT were observed, 80 mg BID was the recommended phase 2 dose (RP2D). Most treatment emergent adverse events (TEAEs) were grade 1 or 2, and grade 3 TEAEs included thrombocytopenia (2/11, 18.2%) and hypertriglyceridemia (3/11, 27.3%). The median time to maximum concentration (T
conclusionsAbexinostat showed favorable tolerability with no DLT in Chinese patients with r/r B cell NHL. The RP2D was 80 mg BID. The plasma concentration was dose-proportional manner. The PK result demonstrated that BID "one week on, one week off" administration is reasonable. Promising anti-tumor activity were seen in these patients population. This result support further investigation.
trial registrationClinicalTrials.gov (NCT04024696). Date of registration: 18 July 2019.
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