page_title: Custirsen
section_title: Side effects
hierarchical_section_title: Custirsen / Side effects
caption_attribution_description: English: CT scan of prostate cancer in a 73-year-old man.
context_page_description: Custirsen, aliases including custirsen sodium, OGX-011, and CC-8490, is an investigational drug that was under clinical testing for the treatment of cancer. It is an antisense oligonucleotide targeting clusterin expression. In metastatic prostate cancer, custirsen showed no benefit in improving over all survival.
  Custirsen was developed through a collaboration of OncoGenex Pharmaceuticals Inc. and Isis. In 2009, OncoGenex Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd agreed to develop and commercialise Custirsen.
context_section_description: A phase I study investigated the maximum tolerated dose of Custirsen in patients with recurrent or refractory high-grade gliomas.
  The recommended and safe dosing of Custirsen was determined in a Phase I same-dose escalation scheme involving forty patients with tumours known to upregulate clusterin with metastatic or locally recurrent disease (prostate, ovary, breast). Custirsen was infused intravenously on days 1, 3, and 5, with weekly dosing starting on day 8 for four weeks. The drug was increasingly administered in six dose cohorts of 40 mg, 80 mg, 160 mg, 320 mg, 480 mg, and 640 mg.
  The results found that the recommended dose of Custirsen was 640 mg, with maximum decrease of clusterin blood plasma occurring at this dose. Researchers found a statistically significant increase in the apoptotic index in prostatectomy specimens.
  This study provided the dosing framework for further studies into Custirsen, determining 640 mg as a tolerable and biologically active dose.
  In this study, no dose-limiting toxicities were reported in doses up to and including 480 mg. For patients who received the 640 mg dose, the following adverse reactions were present:
  Thrombocytopenia
  Anaemia
  Leukopenia
  Fever
  Fatigue
  Rigors
  Alopecia
  Anorexia
  In patients who received combined treatment with Docetaxel, four of sixteen patients experienced dose-limiting toxicities at 640 mg:
  Dyspnea
  Pleural effusion
  Neutropenia
  Fatigue
  Mucositis
caption: CT scan of prostate cancer
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