ArticleClinical cancer research : an official journal of the American Association for Cancer Research2009
Phase I and pharmacokinetic study of pegylated liposomal CKD-602 in patients with advanced malignancies.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers, 1 of them a synthesis that pooled it.
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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Meta-analysis of inter-patient pharmacokinetic variability of liposomal and non-liposomal anticancer agents.Nanomedicine : nanotechnology, biology, and medicine · 2014Pooled it
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- siRNA Therapeutics for Protein Misfolding Diseases of the Central Nervous System.Methods in molecular biology (Clifton, N.J.) · 2021Article
- Lipopeptide Delivery of siRNA to the Central Nervous System.Methods in molecular biology (Clifton, N.J.) · 2019Article
- Camptothecin (CPT) and its derivatives are known to target topoisomerase I (Top1) as their mechanism of action: did we miss something in CPT analogue molecular targets for treating human disease such as cancer?American journal of cancer research · 2017Review
- When Is It Important to Measure Unbound Drug in Evaluating Nanomedicine Pharmacokinetics?Drug metabolism and disposition: the biological fate of chemicals · 2016Review
- Ligand-targeted theranostic nanomedicines against cancer.Journal of controlled release : official journal of the Controlled Release Society · 2016Review
- Advances and Challenges of Liposome Assisted Drug Delivery.Frontiers in pharmacology · 2015Review
- Targeted delivery system of nanobiomaterials in anticancer therapy: from cells to clinics.BioMed research international · 2014Review
- Translational studies of phenotypic probes for the mononuclear phagocyte system and liposomal pharmacology.The Journal of pharmacology and experimental therapeutics · 2013Article
- Microfluidic technique to measure intratumoral transport and calculate drug efficacy shows that binding is essential for doxorubicin and release hampers Doxil.Integrative biology : quantitative biosciences from nano to macro · 2013Article
- Lipopeptide delivery of siRNA to the central nervous system.Methods in molecular biology (Clifton, N.J.) · 2013Article
- Pharmacokinetics and efficacy of PEGylated liposomal doxorubicin in an intracranial model of breast cancer.PloS one · 2013Article
- Nanoparticle delivery systems for cancer therapy: advances in clinical and preclinical research.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2012Review
- Mechanism-based model characterizing bidirectional interaction between PEGylated liposomal CKD-602 (S-CKD602) and monocytes in cancer patients.International journal of nanomedicine · 2012Article
- Treatment of 9L gliosarcoma in rats by ferrociphenol-loaded lipid nanocapsules based on a passive targeting strategy via the EPR effect.Pharmaceutical research · 2011Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
purposeS-CKD602 is a pegylated liposomal formulation of CKD602, a semisynthetic camptothecin analogue. Pegylated (STEALTH) liposomes can achieve extended drug exposure in plasma and tumor. Based on promising preclinical data, the first phase I study of S-CKD602 was done in patients with refractory solid tumors. EXPERIMENTAL
designS-CKD602 was administered i.v. every 3 weeks. Modified Fibonacci escalation was used (three to six patients/cohort), and dose levels ranged from 0.1 to 2.5 mg/m2. Serial plasma samples were obtained over 2 weeks and total (lactone+hydroxyl acid) concentrations of encapsulated, released, and sum total (encapsulated+released) CKD602 measured by liquid chromatography-tandem mass spectrometry.
resultsForty-five patients (21 males) were treated. Median age, 62 years (range, 33-79 years) and Eastern Cooperative Oncology Group status, 0 to 1 (43 patients) and 2 (2 patients). Dose-limiting toxicities of grade 3 mucositis occurred in one of six patients at 0.3 mg/m2, grade 3 and 4 bone marrow suppression in two of three patients at 2.5 mg/m2, and grade 3 febrile neutropenia and anemia in one of six patients at 2.1 mg/m2. The maximum tolerated dose was 2.1 mg/m2. Partial responses occurred in two patients with refractory ovarian cancer (1.7 and 2.1 mg/m2). High interpatient variability occurred in the pharmacokinetic disposition of encapsulated and released CKD602.
conclusionsS-CKD602 represents a promising new liposomal camptothecin analogue with manageable toxicity and promising antitumor activity. Phase II studies of S-CKD602 at 2.1 mg/m2 i.v. once every 3 weeks are planned. Prolonged plasma exposure over 1 to 2 weeks is consistent with STEALTH liposomes and provides extended exposure compared with single doses of nonliposomal camptothecins.
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What OpenQuestion holds
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.