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Early cessation of the clinical development of LiPlaCis, a liposomal cisplatin formulation

To evaluate the safety and tolerability of LiPlaCis, a liposomal formulated platinum compound, in patients with solid tumours and to determine the maximum tolerated dose (MTD) of intravenous (i.v.) LiPlaCis. and to assess plasma and urine pharmacokinetics and plasma biomarkers. Patients with solid t... Full description

Journal Title: European Journal of Cancer November 2010, Vol.46(16), pp.3016-3021
Main Author: de Jonge, Maja J.A
Other Authors: Slingerland, Marije , Loos, Walter J , Wiemer, Erik A.C , Burger, Herman , Mathijssen, Ron H.J , Kroep, Judith R , Den Hollander, Margret A.G , van Der Biessen, Diane , Lam, Mei-Ho , Verweij, Jaap , Gelderblom, Hans
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 0959-8049 ; E-ISSN: 1879-0852 ; DOI: 10.1016/j.ejca.2010.07.015
Link: https://www.sciencedirect.com/science/article/pii/S0959804910006933
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recordid: elsevier_sdoi_10_1016_j_ejca_2010_07_015
title: Early cessation of the clinical development of LiPlaCis, a liposomal cisplatin formulation
format: Article
creator:
  • de Jonge, Maja J.A
  • Slingerland, Marije
  • Loos, Walter J
  • Wiemer, Erik A.C
  • Burger, Herman
  • Mathijssen, Ron H.J
  • Kroep, Judith R
  • Den Hollander, Margret A.G
  • van Der Biessen, Diane
  • Lam, Mei-Ho
  • Verweij, Jaap
  • Gelderblom, Hans
subjects:
  • Liplacis
  • Liposomal
  • Cisplatin
  • Phase I
  • Solid Tumour
  • Medicine
ispartof: European Journal of Cancer, November 2010, Vol.46(16), pp.3016-3021
description: To evaluate the safety and tolerability of LiPlaCis, a liposomal formulated platinum compound, in patients with solid tumours and to determine the maximum tolerated dose (MTD) of intravenous (i.v.) LiPlaCis. and to assess plasma and urine pharmacokinetics and plasma biomarkers. Patients with solid tumours without standard therapeutic options were enrolled to receive LiPlaCis administered as a 1 h infusion without additional hydration every 3 weeks until RECIST progression or unacceptable toxicity. Cohorts of 3–6 patients were treated at each dose level until MTD was reached. Eighteen patients were enrolled and 64 cycles were delivered. At the first dose level 3 patients experienced an infusion reaction. Despite prophylactic pre-medication and prolongation of the infusion to 2 h in further patients, three other patients had mild acute infusion reactions. Toxicity at the fifth dose level...
language: eng
source:
identifier: ISSN: 0959-8049 ; E-ISSN: 1879-0852 ; DOI: 10.1016/j.ejca.2010.07.015
fulltext: fulltext
issn:
  • 0959-8049
  • 09598049
  • 1879-0852
  • 18790852
url: Link


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titleEarly cessation of the clinical development of LiPlaCis, a liposomal cisplatin formulation
creatorde Jonge, Maja J.A ; Slingerland, Marije ; Loos, Walter J ; Wiemer, Erik A.C ; Burger, Herman ; Mathijssen, Ron H.J ; Kroep, Judith R ; Den Hollander, Margret A.G ; van Der Biessen, Diane ; Lam, Mei-Ho ; Verweij, Jaap ; Gelderblom, Hans
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subjectLiplacis ; Liposomal ; Cisplatin ; Phase I ; Solid Tumour ; Medicine
descriptionTo evaluate the safety and tolerability of LiPlaCis, a liposomal formulated platinum compound, in patients with solid tumours and to determine the maximum tolerated dose (MTD) of intravenous (i.v.) LiPlaCis. and to assess plasma and urine pharmacokinetics and plasma biomarkers. Patients with solid tumours without standard therapeutic options were enrolled to receive LiPlaCis administered as a 1 h infusion without additional hydration every 3 weeks until RECIST progression or unacceptable toxicity. Cohorts of 3–6 patients were treated at each dose level until MTD was reached. Eighteen patients were enrolled and 64 cycles were delivered. At the first dose level 3 patients experienced an infusion reaction. Despite prophylactic pre-medication and prolongation of the infusion to 2 h in further patients, three other patients had mild acute infusion reactions. Toxicity at the fifth dose level...
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