AMG706 (Motesanib) disposition in patients with advanced solid tumours

• Research type

  Research Study

• Full title

  An Open-label, Single Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-labelled AMG706(Motesanib)Followed by Extended Treatment with Motesanib in Patients with Advanced Solid Tumors

• IRAS ID

  16506

• Contact name

  Sally Clive

• Sponsor organisation

  AMGEN Inc

• Eudract number

  2008-006339-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Cancer cells produce chemicals that stimulate new blood vessel growth to enable the cancer to keep growing. Medicines that block the growth of these new blood vessels can help treat cancer. Motesanib is a new drug that blocks cancer blood vessel growth. A number of early clinical trials of motesanib have been completed, clarifying how best to give it and its main side effects (diarrhoea, fatigue, high blood pressure, nausea). Further detail as to how the human body absorbs, distributes, breaks down (metabolises) and gets rid of (excretes) the drug is required in order to advance the clinical development of this new anticancer drug. This study aims to provide this detail.Between 4 and 6 eligible patients, who have advanced cancer for which no standard therapy exists, will be recruited from the Edinburgh Cancer Centre clinics. Patients will be admitted to the Charles River Research facility for the Ó?core? phase of the study, where they will stay for 6-8 days. A radiolabel-tagged single oral dose of motesanib will be given. The amount of radioactivity is very small but enables the drug and its breakdown products to be followed through the body. Blood, urine and stool will be collected and analysed for radioactivity and metabolites. Patients will stay in the Research facility for 6 to 8 days before returning to the Edinburgh Cancer Centre. They will then enter the Ó?extension phase? of the study (as long as this is still appropriate) and take oral motesanib daily at home. Blood pressure will be checked regularly using a home blood pressure monitor, and clinic visits will be every 4 weeks. Treatment will continue as long as there is no progression of cancer growth and there are no safety/other reasons to withdraw treatment. The research is being funded by Amgen Inc.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/23

• Date of REC Opinion

  2 Apr 2009

• REC opinion

  Favourable Opinion