Trial reportCancer chemotherapy and pharmacology2013
Pharmacokinetic study of omacetaxine mepesuccinate administered subcutaneously to patients with advanced solid and hematologic tumors.
Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 50 citations in OpenAlex.
- A phase II study of omacetaxine mepesuccinate for patients with higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia after failure of hypomethylating agents.American journal of hematology · 2019Trial
- A perfused, parallelized blood brain barrier-tumor platform for compound permeation and efficacy investigations.Microsystems & nanoengineering · 2026Article
- Omacetaxine reduces c-Myc expression and demonstrates antitumor effects in osteosarcoma.Scientific reports · 2026Article
- Omacetaxine and venetoclax in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with mutant RUNX1.Blood neoplasia · 2025Article
- Sensitivity to an inhibitor of translation elongation in solid and hematologic cancers.Scientific reports · 2025Article
- A Repurposed Drug Selection Pipeline to Identify CNS-Penetrant Drug Candidates for Glioblastoma.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Elucidating host cell response pathways and repurposing therapeutics for SARS-CoV-2 and other coronaviruses.Scientific reports · 2022Article
- Inhibition of the CDK2 and Cyclin A complex leads to autophagic degradation of CDK2 in cancer cells.Nature communications · 2022Article
- Targeting the translational machinery in gastrointestinal stromal tumors (GIST): a new therapeutic vulnerability.Scientific reports · 2022Article
- Exploiting Protein Translation Dependence in Multiple Myeloma with Omacetaxine-Based Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Observational
- Severe fever with thrombocytopenia syndrome virus (SFTSV)-host interactome screen identifies viral nucleoprotein-associated host factors as potential antiviral targets.Computational and structural biotechnology journal · 2021Article
- A proposal for clinical trials of COVID-19 treatment using homo-harringtonine.National science review · 2021Article
- Therapeutic drugs for SARS-CoV-2 treatment: Current state and perspective.International immunopharmacology · 2021Review
- A high throughput screen for TMPRSS2 expression identifies FDA-approved and clinically advanced compounds that can limit SARS-CoV-2 entry.Research square · 2020Article
- Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro.Antiviral research · 2020Article
- Natural Plant Products: A Less Focused Aspect for the COVID-19 Viral Outbreak.Frontiers in plant science · 2020Review
- Homoharringtonine, an approved anti-leukemia drug, suppresses triple negative breast cancer growth through a rapid reduction of anti-apoptotic protein abundance.American journal of cancer research · 2019Article
- Homoharringtonine interacts synergistically with bortezomib in NHL cells through MCL-1 and NOXA-dependent mechanisms.BMC cancer · 2018Article
- Novel homobarringtonie-containing therapy for the treatment of patients with primary acute myeloid leukemia that are resistant to conventional therapy.Oncology letters · 2017Article
- Pharmacokinetics and excretion of (14)C-omacetaxine in patients with advanced solid tumors.Investigational new drugs · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOmacetaxine mepesuccinate is a first-in-class cephalotaxine demonstrating clinical activity in chronic myeloid leukemia. A subcutaneous (SC) formulation demonstrated efficacy and safety in phase 1/2 trials in patients previously treated with ≥1 tyrosine kinase inhibitor. This study assessed pharmacokinetics and safety of SC omacetaxine in patients with advanced cancers.
methodsOmacetaxine 1.25 mg/m(2) SC was administered BID, days 1-14 every 28 days for 2 cycles, until disease progression or unacceptable toxicity. Blood and urine were collected to measure omacetaxine concentrations and inactive metabolites. Adverse events, including QT interval prolongation, were recorded. Tumor response was assessed at cycle 2 completion.
resultsPharmacokinetic parameters were estimated from cycle 1, day 1 data in 21 patients with solid tumors or hematologic malignancies and cycle 1, day 11 data in 10 patients. Omacetaxine was rapidly absorbed, with mean peak plasma concentrations observed within 1 h, and widely distributed, as evidenced by an apparent volume of distribution of 126.8 L/m(2). Plasma concentration versus time data demonstrated biexponential decay; mean steady-state terminal half-life was 7 h. Concentrations of inactive metabolites 4'-DMHHT and cephalotaxine were approximately 10 % of omacetaxine and undetectable in most patients, respectively. Urinary excretion of unchanged omacetaxine accounted for <15 % of the dose. Grade 3/4 drug-related adverse events included thrombocytopenia (48 %) and neutropenia (33 %). Two grade 2 increases in QTc interval (>470 ms) were observed and were not correlated with omacetaxine plasma concentration. No objective responses were observed.
conclusionsOmacetaxine is well absorbed after SC administration. Therapeutic plasma concentrations were achieved with 1.25 mg/m(2) BID, supporting clinical development of this dose and schedule.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.