Advanced

Bone-targeted novel cytotoxic polybisphosphonate conjugate in castration-resistant prostate cancer : A multicenter phase 1 study

Thellenberg-Karlsson, Camilla; Nyman, Claes; Nilsson, Sten LU ; Blom, Rene LU ; Marquez, Marcela; Castellanos, Enrique and Holmberg, Anders R. (2016) In Anticancer Research 36(12). p.6499-6504
Abstract

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... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Bone-targeting, CRPC, Cytotoxic, Metastasis, Polybisphosphonate
in
Anticancer Research
volume
36
issue
12
pages
6 pages
publisher
International Institute of Cancer Research
external identifiers
  • scopus:85001955804
ISSN
0250-7005
language
English
LU publication?
yes
id
e8e49f24-ee95-4fa5-aa86-942e6c970a7e
alternative location
http://ar.iiarjournals.org/content/36/12/6499.abstract
date added to LUP
2016-12-28 16:11:04
date last changed
2017-11-14 09:50:45
@article{e8e49f24-ee95-4fa5-aa86-942e6c970a7e,
  abstract     = {<p>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.</p>},
  author       = {Thellenberg-Karlsson, Camilla and Nyman, Claes and Nilsson, Sten and Blom, Rene and Marquez, Marcela and Castellanos, Enrique and Holmberg, Anders R.},
  issn         = {0250-7005},
  keyword      = {Bone-targeting,CRPC,Cytotoxic,Metastasis,Polybisphosphonate},
  language     = {eng},
  month        = {12},
  number       = {12},
  pages        = {6499--6504},
  publisher    = {International Institute of Cancer Research},
  series       = {Anticancer Research},
  title        = {Bone-targeted novel cytotoxic polybisphosphonate conjugate in castration-resistant prostate cancer : A multicenter phase 1 study},
  volume       = {36},
  year         = {2016},
}