Trial reportAdvances in therapy2019
Maximum Tolerated Dose and Pharmacokinetics of Paclitaxel Micellar in Patients with Recurrent Malignant Solid Tumours: A Dose-Escalation Study.
Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 30 citations in OpenAlex.
- Recent paclitaxel formulation strategies: expanding the therapeutic index by addressing biopharmaceutical and toxicity limitations.Archives of pharmacal research · 2026Review
- Responsive nanomedicine strategies achieve pancreatic cancer precise theranostics.Bioactive materials · 2026Review
- A Library of Custom PEG-Lipids reveals a Double-PEG-Lipid with Drastically Enhanced Paclitaxel Solubility and Human Cancer Cell Cytotoxicity when used in Fluid Micellar Nanoparticles.bioRxiv : the preprint server for biology · 2024Article
- Paclitaxel Drug-Drug Interactions in the Military Health System.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2024Article
- Polymeric Nanoparticles for Drug Delivery.Chemical reviews · 2024Review
- Formulation-dependent differences in paclitaxel distribution to anatomical sites relevant to chemotherapy-induced peripheral neuropathy.Frontiers in pharmacology · 2024Article
- Nab-Paclitaxel in the Treatment of Gastrointestinal Cancers-Improvements in Clinical Efficacy and Safety.Biomedicines · 2023Review
- Natural Taxanes: From Plant Composition to Human Pharmacology and Toxicity.International journal of molecular sciences · 2022Review
- Anticancer Nanotherapeutics in Clinical Trials: The Work behind Clinical Translation of Nanomedicine.International journal of molecular sciences · 2022Review
- Beyond Formulation: Contributions of Nanotechnology for Translation of Anticancer Natural Products into New Drugs.Pharmaceutics · 2022Review
- Enhanced Anti-Tumor Effect of Folate-Targeted FA-AMA-hyd-DOX Conjugate in a Xenograft Model of Human Breast Cancer.Molecules (Basel, Switzerland) · 2021Article
- Recent progress in nanomedicine for enhanced cancer chemotherapy.Theranostics · 2021Review
- A Compressive Review about TaxolMolecules (Basel, Switzerland) · 2020Review
- Pharmacokinetics of Total and Unbound Paclitaxel After Administration of Paclitaxel Micellar or Nab-Paclitaxel: An Open, Randomized, Cross-Over, Explorative Study in Breast Cancer Patients.Advances in therapy · 2019Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA water-soluble Cremophor EL-free formulation of paclitaxel, in which retinoic acid derivates solubilize paclitaxel by forming micelles (paclitaxel micellar), was studied for the first time in man to establish the maximum tolerated dose (MTD) and to characterize the pharmacokinetics (PK).
methodsThis was an open-label, one-arm, dose-escalating study in patients with advanced solid malignant tumours, for which no standard therapy was available or had failed. Paclitaxel micellar was given as 1-h intravenous infusion every 21 days for 3 cycles, mainly without premedication. Plasma samples were collected during 24 h at the first cycle and paclitaxel concentrations were assayed by high-performance liquid chromatography. PK was evaluated using a two-compartment model.
resultsThirty-four patients received paclitaxel micellar at doses ranging between 90 and 275 mg/m
conclusionNo new side effects unknown for paclitaxel were observed. Maximum plasma concentration (C
trial registrationEudraCT no: 2004-001821-54.
fundingOasmia Pharmaceutical AB.
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Registered trials
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.