Evidence map›Paper›PMID 38878207›Full record

ArticleCancer chemotherapy and pharmacology2024

Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial.

Anna M Mc Laughlin, Dagmar Hess, Robin Michelet, Ilaria Colombo, Simon Haefliger, Sara Bastian, Manuela Rabaglio, Michael Schwitter, Stefanie Fischer, Katrin Eckhardt and 9 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03387917 (TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03387917 phase1terminatednot on this map

TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors: A Multicenter Open-label Single-arm Phase I Trial

TypeinterventionalSponsorSwiss Cancer InstituteRan2018 to 2023Enrolled12ConditionsAdvanced Solid TumorsArmsTLD-1, Caelyx
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Anna M Mc Laughlin *Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr. 31, 12169, Berlin, Germany.
Dagmar Hess *Department of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacher Strasse 95, 9007, St. Gallen, Switzerland.
Robin MicheletDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr. 31, 12169, Berlin, Germany.
Ilaria ColomboDepartment of Medical Oncology, Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland.
Simon HaefligerDepartment of Medical Oncology, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland.
Sara BastianDepartment of Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Manuela RabaglioDepartment of Medical Oncology, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland.
Michael SchwitterOncology/Hematology, Kantonsspital Graubünden, Chur, Switzerland.
Stefanie FischerDepartment of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacher Strasse 95, 9007, St. Gallen, Switzerland.
Katrin EckhardtCoordinating Center, Swiss Group for Clinical Cancer Research, Bern, Switzerland.
Stefanie HayozCoordinating Center, Swiss Group for Clinical Cancer Research, Bern, Switzerland.
Christoph KoppCoordinating Center, Swiss Group for Clinical Cancer Research, Bern, Switzerland.
Marian KloseDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr. 31, 12169, Berlin, Germany.
Cristiana SessaDepartment of Medical Oncology, Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland.
Anastasios StathisOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland.
Stefan HalbherrInnomedica Switzerland AG, Bern, Switzerland.
Wilhelm HuisingaInstitute of Mathematics, University of Potsdam, Potsdam, Germany.
Markus Joerger *Department of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacher Strasse 95, 9007, St. Gallen, Switzerland. markus.joerger@kssg.ch.
Charlotte Kloft *Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr. 31, 12169, Berlin, Germany. charlotte.kloft@fu-berlin.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTLD-1 is a novel pegylated liposomal doxorubicin (PLD) formulation aiming to optimise the PLD efficacy-toxicity ratio. We aimed to characterise TLD-1's population pharmacokinetics using non-compartmental analysis and nonlinear mixed-effects modelling.

methodsThe PK of TLD-1 was analysed by performing a non-compartmental analysis of longitudinal doxorubicin plasma concentration measurements obtained from a clinical trial in 30 patients with advanced solid tumours across a 4.5-fold dose range. Furthermore, a joint parent-metabolite PK model of doxorubicin

resultsMedians

conclusionThe population PK of TLD-1, including its release and main metabolite, were successfully characterised using non-compartmental and compartmental analyses. Based on its long half-life, TLD-1 presents a promising candidate for further clinical development. The PK characteristics form the basis to investigate TLD-1 exposure-response (i.e., clinical efficacy) and exposure-toxicity relationships in the future. Once such relationships have been established, the developed population PK model can be further used in model-informed precision dosing strategies. CLINICAL

trial registrationClinicalTrials.gov-NCT03387917-January 2, 2018.

Indexed as

Antibiotics, AntineoplasticDoxorubicinNeoplasmsPolyethylene GlycolsAdultAgedArea Under CurveDose-Response Relationship, DrugFemaleHalf-LifeHumansMaleMiddle AgedModels, BiologicalAntibiotics, AntineoplasticDoxorubicinliposomal doxorubicinPolyethylene GlycolsDoxorubicinLiposomesNanoparticlesNonlinear mixed-effects modelPharmacokineticsPharmacometrics

Identifiers

PMID38878207
PMCPMC11420315

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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.