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Bone-targeted Novel Cytotoxic Polybisphosphonate Conjugate in Castration-resistant Prostate Cancer: A Multicenter Phase 1 Study
Norrlands University Hospital, Umeå, Sweden.
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2016 (English)In: Anticancer Research, ISSN 0250-7005, E-ISSN 1791-7530, Vol. 36, no 12, 6499-6504 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Osteodex (ODX) is a cytotoxic bone-targeting polybisphosphonate, intended for treatment of bone metastasis from castration-resistant prostate cancer (CRPC). The primary objective of this study was to describe the tolerability and toxicity of such treatment by defining its maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).

PATIENTS AND METHODS: Twenty-eight patients with castration-resistant prostate cancer and confirmed bone metastasis were assigned to seven infusions of ODX every third week, divided in seven ascending dose cohorts.

RESULTS: No DLT's were observed and as pre-specified, the highest dose administered was defined as MTD. In total, 206 adverse events (AE) were recorded and 13,6% were classified as treatment-related, while none were serious or severe (SAE). No cumulative toxicity and no renal toxicity were recorded.

CONCLUSION: ODX was well tolerated, with few and mild side-effects and with apparent treatment efficacy in the highest dose cohort. Further clinical development is currently in progress.

Place, publisher, year, edition, pages
International Institute of Anticancer Research, 2016. Vol. 36, no 12, 6499-6504 p.
Keyword [en]
CRPC, Polybisphosphonate, bone-targeting, cytotoxic, metastasis
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:umu:diva-134362DOI: 10.21873/anticanres.11249ISI: 000390946700035PubMedID: 27919973OAI: oai:DiVA.org:umu-134362DiVA: diva2:1092621
Available from: 2017-05-03 Created: 2017-05-03 Last updated: 2017-05-08Bibliographically approved

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Thellenberg-Karlsson, Camilla
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Citation style
  • apa
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  • modern-language-association-8th-edition
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  • de-DE
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  • en-US
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  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
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Output format
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  • asciidoc
  • rtf