AZD8931 vs Paclitaxel in Gastric or Gastro-oesophageal Junction Cancer
Research type
Research Study
Full title
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)
IRAS ID
112766
Contact name
David Cunningham
Sponsor organisation
AstraZeneca UK
Eudract number
2011-005194-23
Clinicaltrials.gov Identifier
Research summary
Gastric cancer is the second most common cause of death from cancer, with 700,000 deaths annually across the world. Laboratory studies have shown that a new drug, AZD8931 can block the growth of gastric cancer cells. This study will investigate the safety and effectiveness of this potential new medicine for the treatment of metastatic gastric or gastro-oesophageal junction cancer in patients who have already received chemotherapy and who cannot be treated further with the current standard treatment of trastuzumab. Suitability for treatment with trastuzumab is dependent on the type of tumour; which is checked by taking a biopsy from the tumour. In this study the tumour status to enrol will be via an archival sample and assessed locally. All patients in the study will receive treatment with the standard chemotherapy drug paclitaxel. Patients will then be randomly assigned (like the toss of a coin) to also take either AZD8931 or placebo. The aim of the study is to assess the efficacy of AZD8931 plus paclitaxel compared with placebo plus paclitaxel by comparison of the change in tumour size after 8 weeks of treatment. The study will also explore the tumour status of patients before they start the study treatment to see if this might show whether AZD8931 is more or less effective for certain types of tumour. This will involve a new biopsy being taken from patients who take part in the study. The study will recruit about 60 patients in total, aged 18 years or over. During the study patients will be asked to attend hospital visits on a regular basis and will undergo assessments to check on their health and to see how the drug is working. Patients can remain on AZD8931/Placebo or/and paclitaxel treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
12/SC/0560
Date of REC Opinion
19 Nov 2012
REC opinion
Further Information Favourable Opinion