Trial reportEuropean journal of clinical pharmacology2016
Panobinostat PK/PD profile in combination with bortezomib and dexamethasone in patients with relapsed and relapsed/refractory multiple myeloma.
Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed.
- Review
- Adverse drug reaction profiles of histone deacetylase inhibitors.Scientific reports · 2025Article
- Article
- Drug-Drug Interactions Involving Dexamethasone in Clinical Practice: Myth or Reality?Journal of clinical medicine · 2023Review
- HER3 targeting augments the efficacy of panobinostat in claudin-low triple-negative breast cancer cells.NPJ precision oncology · 2023Article
- PDI inhibitor LTI6426 enhances panobinostat efficacy in preclinical models of multiple myeloma.Cancer chemotherapy and pharmacology · 2022Article
- A pilot study of 3D tissue-engineered bone marrow culture as a tool to predict patient response to therapy in multiple myeloma.Scientific reports · 2021Observational
- A novel dual HDAC and HSP90 inhibitor, MPT0G449, downregulates oncogenic pathways in human acute leukemia in vitro and in vivo.Oncogenesis · 2021Article
- Therapeutic drug monitoring of oral targeted antineoplastic drugs.European journal of clinical pharmacology · 2021Review
- High-throughput screening identifies histone deacetylase inhibitors that modulate GTF2I expression in 7q11.23 microduplication autism spectrum disorder patient-derived cortical neurons.Molecular autism · 2020Article
- Improved killing of HIV-infected cells using three neutralizing and non-neutralizing antibodies.The Journal of clinical investigation · 2020Article
- Clinical Pharmacokinetics and Pharmacodynamics of Panobinostat.Clinical pharmacokinetics · 2018Review
- Epigenetic therapy approaches in non-small cell lung cancer: Update and perspectives.Epigenetics · 2016Review
- Histone Deacetylases as New Therapeutic Targets in Triple-negative Breast Cancer: Progress and Promises.Cancer genomics & proteomicsReview
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePanobinostat, a potent pan-deacetylase inhibitor, improved progression-free survival (PFS) in patients with relapsed and refractory multiple myeloma when combined with bortezomib and dexamethasone in a phase 3 trial, PANORAMA-1. This study aims to explore exposure-response relationship for panobinostat in this combination in a phase 1 trial, B2207 and contrast with data from historical single-agent studies.
methodsPanobinostat plasma concentration-time profiles were obtained in patients from PANORAMA-1 (n = 12) and B2207 (n = 12) trials. Overall response rates (ORR) and major adverse events (AE) by panobinostat exposure were investigated in the B2207 trial. Panobinostat PK data from combination trials were contrasted with data from single-agent studies.
resultsAt maximum tolerated dose (MTD), the geometric mean of panobinostat area under curve from 0 to 24 h (AUC0-24) was 47.5 ng h/mL (77 % CV), and maximum plasma concentration (Cmax) was 8.1 ng/mL (90 % CV). These values were comparable with exposure data obtained in PANORAMA-1, but were 20 % lower than those without dexamethasone, and ∼ 50 % lower from single-agent trials, likely due to enzyme induction by dexamethasone. Higher levels of panobinostat exposure were associated with higher response rates and higher incidences of diarrhea and thrombocytopenia.
conclusionsApparent panobinostat exposure-AE and exposure-ORR relationships were observed when combined with bortezomib and dexamethasone in the treatment of patients with relapsed and refractory multiple myeloma. The addition of dexamethasone facilitated best response even though plasma exposure of panobinostat was reduced. Combination with a strong enzyme inducer should be avoided in future trials to prevent further reduction of panobinostat exposure.
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