Evidence map›Paper›PMID 41252081›Full record

Trial reportClinical pharmacokinetics2026

TLD-1, a Novel Liposomal Doxorubicin, in Patients with Solid Tumors: Comparative Pharmacokinetics and Final Results of a Multicenter Phase 1 Study (SAKK 65/16).

Marian Klose, Ilaria Colombo, Katrin Gobat, Kira-Lee Koster, Simon Haefliger, Manuela Rabaglio, Sara Bastian, Michael Schwitter, Ursina Zürrer-Härdi, Katrin Eckhardt and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Marian Klose *Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, 12169, Berlin, Germany.ORCID 0009-0005-1706-6289
Ilaria Colombo *Oncology Institute of Southern Switzerland, EOC, 6500, Bellinzona, Switzerland.ORCID 0000-0002-0602-8667
Katrin GobatCompetence Center of SAKK, 3008, Bern, Switzerland.
Kira-Lee KosterDepartment of Medical Oncology and Hematology, Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.ORCID 0000-0002-6549-8124
Simon HaefligerDepartment of Medical Oncology, 3010, InselspitalBern, Switzerland.ORCID 0000-0002-9721-3314
Manuela RabaglioDepartment of Medical Oncology, 3010, InselspitalBern, Switzerland.ORCID 0000-0002-6764-1844
Sara BastianDepartment of Medical Oncology and Hematology, Cantonal Hospital, 7000, Chur, Switzerland.
Michael SchwitterDepartment of Medical Oncology and Hematology, Cantonal Hospital, 7000, Chur, Switzerland.
Ursina Zürrer-HärdiKantonsspital Winterthur, 8400, Winterthur, Switzerland.
Katrin EckhardtCompetence Center of SAKK, 3008, Bern, Switzerland.
Stefanie HayozCompetence Center of SAKK, 3008, Bern, Switzerland.ORCID 0000-0002-2265-6559
Stefan HalbherrInnoMedica Holding AG, 3012, Bern, Switzerland.ORCID 0009-0007-3641-6795
Cristiana SessaOncology Institute of Southern Switzerland, EOC, 6500, Bellinzona, Switzerland.
Robin MicheletDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, 12169, Berlin, Germany.ORCID 0000-0002-5485-607X
Anna M Mc LaughlinDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, 12169, Berlin, Germany.ORCID 0000-0002-5936-1877
Dagmar HessDepartment of Medical Oncology and Hematology, Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.ORCID 0009-0007-4993-8744
Anastasios StathisOncology Institute of Southern Switzerland, EOC, 6500, Bellinzona, Switzerland.ORCID 0000-0002-2859-7529
Charlotte Kloft *Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, 12169, Berlin, Germany.
Markus Joerger *Department of Medical Oncology and Hematology, Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. markus.joerger@h-och.ch.ORCID 0000-0001-6602-6287

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveTargeted liposomal doxorubicin (TLD-1) is a novel PEGylated liposomal doxorubicin (PLD) with optimized formulation characteristics, developed to improve the benefit-risk profile of PLD. This randomized intrapatient crossover amendment to the phase 1 SAKK 65/16 trial (NCT03387917) compared the pharmacokinetics (PK) of TLD-1 and Caelyx™ and included a pooled analysis of safety and preliminary antitumor activity at the recommended phase 2 dose (RP2D).

methodsPatients with advanced breast or platinum-resistant ovarian cancer in the comparative PK part were randomized to receive TLD-1 in cycle 1 and Caelyx™ in cycle 2, or vice versa, followed by TLD-1 thereafter. Both formulations were administered intravenously at 40 mg/m

resultsIn 10 evaluable patients from the comparative PK part, TLD-1 showed higher encapsulated doxorubicin exposure (AUC

conclusionsTargeted liposomal doxorubicin demonstrated prolonged systemic circulation and low variability in liposomal drug release, likely due to its formulation characteristics. At 40 mg/m CLINICALTRIALS: GOV IDENTIFIER: NCT03387917, registered 2017-11-21.

Indexed as

Antibiotics, AntineoplasticBreast NeoplasmsDoxorubicinOvarian NeoplasmsPolyethylene GlycolsAdultAgedCross-Over StudiesFemaleHumansMiddle AgedAntibiotics, AntineoplasticDoxorubicinliposomal doxorubicinPolyethylene Glycols

Identifiers

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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.