First-in-human phase I study of the microtubule inhibitor plocabulin in patients with advanced solid tumors.


Journal

Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330

Informations de publication

Date de publication:
08 2019
Historique:
received: 25 07 2018
accepted: 02 10 2018
pubmed: 10 11 2018
medline: 7 2 2020
entrez: 10 11 2018
Statut: ppublish

Résumé

Background Plocabulin (PM060184) is a novel marine-derived microtubule inhibitor that acts as an antitumor agent. This first-in-human study evaluated dose-limiting toxicities (DLT) to define the maximum tolerated dose (MTD) and phase II recommended dose (RD) of plocabulin given as a 10-min infusion on Day (D) 1, D8 and D15 every four weeks. Patients and methods Forty-four patients with advanced solid tumors received plocabulin following an accelerated titration design. Results Plocabulin was escalated from 1.3 mg/m

Identifiants

pubmed: 30411218
doi: 10.1007/s10637-018-0674-x
pii: 10.1007/s10637-018-0674-x
doi:

Substances chimiques

Antineoplastic Agents 0
Polyketides 0
Pyrones 0
Tubulin Modulators 0
plocabulin 52Y8L60CR7

Types de publication

Clinical Trial, Phase I Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

674-683

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Auteurs

Elena Elez (E)

Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Carlos Gomez-Roca (C)

Clinical Research Unit, Institut Claudius Regaud, IUCT- Oncopole, 1 avenue Joliot-Curie, Toulouse, 31059, France.

Arturo Soto Matos-Pita (A)

Pharma Mar, S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.

Guillem Argiles (G)

Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Thibaud Valentin (T)

Clinical Research Unit, Institut Claudius Regaud, IUCT- Oncopole, 1 avenue Joliot-Curie, Toulouse, 31059, France.

Cinthya Coronado (C)

Pharma Mar, S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.

Jorge Iglesias (J)

Pharma Mar, S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.

Teresa Macarulla (T)

Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Sarah Betrian (S)

Clinical Research Unit, Institut Claudius Regaud, IUCT- Oncopole, 1 avenue Joliot-Curie, Toulouse, 31059, France.

Salvador Fudio (S)

Pharma Mar, S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.

Katrin Zaragoza (K)

Pharma Mar, S.A., Clinical R&D, Colmenar Viejo, Madrid, Spain.

Josep Tabernero (J)

Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Jean-Pierre Delord (JP)

Clinical Research Unit, Institut Claudius Regaud, IUCT- Oncopole, 1 avenue Joliot-Curie, Toulouse, 31059, France. Delord.Jean-Pierre@iuct-oncopole.fr.

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Classifications MeSH