AZD4547 v Paclitaxel in Gastric or Gastro-oesophageal Junction Cancer

• Research type

  Research Study

• Full title

  A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study)

• IRAS ID

  69739

• Contact name

  Abdul Wasat Mansoor

• Sponsor organisation

  AstraZeneca

• Eudract number

  2010-023377-19

• ISRCTN Number

  na

• Research summary

  AstraZeneca is conducting a research study that will compare AZD4547 (a potential new medicine) with the chemotherapy drug, paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer who have received prior treatment with chemotherapy. Studies done in the laboratory have shown that AZD4547 helps stop growth of some human cancer cells, including gastric cancer cell lines, therefore patients may benefit from the study, but there is no guarantee. When some cancers progress despite treatment, this is often due to a process whereby multiple copies of a gene called FGFR2 are produced. This gene is particularly associated with advanced cancers, and the medicine we are testing specifically targets this gene. Only patients with tumours that have elevated FGFR2 levels can take part in the study. In order to see if the tumour has multiple copies of this gene, patients need to give their consent to test a sample of their tumour. Participants of this study will be assigned randomly (by chance) to receive either AZD4547 or paclitaxel. It??s important to note that neither the patient, nor the doctor or study team, would be allowed to choose which treatment regimen patients are assigned. If patients consent to enter this study they will be asked to attend hospital visits a regular basis and will undergo assessments to check on their health and to see how the drug is working. Patients can remain on AZD4547 or paclitaxel treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0376

• Date of REC Opinion

  3 Nov 2011

• REC opinion

  Further Information Favourable Opinion