POP12251-PK & Safety of Cabazitaxel in patients with solid tumours

• Research type

  Research Study

• Full title

  POP12251: An open-label pharmacokinetic and safety study of cabazitaxel in patients with solid tumors with moderately and severely impaired and with normal renal function

• IRAS ID

  93143

• Contact name

  Ruth Plummer

• Sponsor organisation

  Sanofi Rechereche & Developpement

• Eudract number

  2011-001517-14

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This clinical trial is to study how kidney dysfunction may change how the study drug (XRP6258, Cabazitaxel, commercial name: Jevtana) is handled in the body (pharmacokinetics). Patients with a diagnosis of advanced cancers of different types that are refractory (unresponsive) to standard therapy or for which no standard therapy exists, who have moderate and severe degrees of renal impairment, and also patients with normal renal function will be eligible for this study. Cabazitaxel is a novel chemotherapy which exhibits a broad spectrum of anti-tumour activity. Currently, Cabazitaxel is licensed for treatment of advanced prostate cancer. It has been well studied in phase 1, 2 and 3 studies, however, limited data are available for patients with moderate kidney dysfunction and no data are available for patients with severe kidney dysfunction or end stage kidney disease. In human, Cabazitaxel is metabolized by liver enzymes and is only minimally excreted via the kidneys. This clinical trial is to study how Cabazitaxel is handled in patients with moderate and severe kidney dysfunction. This study is also a post-marketing requirement from the EMEA.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  12/NE/0028

• Date of REC Opinion

  27 Feb 2012

• REC opinion

  Favourable Opinion