AUY922 versus docetaxal or irinitecan in Gastric Cancer patients

• Research type

  Research Study

• Full title

  A randomized, open-label, multi-center phase II study to compare AUY922 with docetaxel or irinotecan in adult patients with advanced gastric cancer, who have progressed after one line of chemotherapy

• IRAS ID

  43034

• Contact name

  Ian Chau

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-015407-47

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The purpose of this study is to help answer questions about how well AUY922 works compared to two other treatments (docetaxel and irinotecan) and its benefits and risks for people who have failed prior treatment for their advanced gastric cancer. AUY922 is a new investigational drug, which interferes with the folding of proteins in cancer cells and causes them to die.AUY922 has been tested extensively in the laboratory but has only been tested in about 125 other people with various cancers. AUY922 has shown effects on gastric cancer in both laboratory and Phase 1 human studies. Patients will receive either AUY922 or the comparator (docetaxel or irinotecan -depending on prior treatment) AUY922 will be administered weekly by infusion and docetaxel or irinotecan will be administered every 21 days by infusion. This is an open label study, which means that both the patient and the doctor will know which medication the patient is taking. Patients will visit the study hospital between 3 and 5 times every cycle (three weeks) for routine check-ups and they will have scans every 6 weeks to determine the tumour status. Each participant will receive study medication until disease progression, unacceptable side effects or withdrawal of consent. Patients will then be contacted every three months to see how they are. Approximately 120 patients will take part in this study in about 35 centres around the world (Europe, Asia, North America and Australia). This study is being organised by Novartis Pharmaceuticals Corporation of Florham Park, New Jersey 07932 USA.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/32

• Date of REC Opinion

  7 Jul 2010

• REC opinion

  Further Information Favourable Opinion