Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

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)

The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

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)

Inclusion Criteria:

• Male or female aged 18 years or older (20 years or older in Japan)
• Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
• Suitable for paclitaxel therapy.
• At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
• Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2

Exclusion Criteria:

• Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
• Any prior taxane therapy (at any time from diagnosis of gastric cancer)
• Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
• Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
• Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy