Efficacy and safety of AZD4547 versus paclitaxel in patients with Advanced Gastric or Gastro-oesophageal Cancer - SHINE

Exclusion Criteria

• - Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
• - Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months;
• Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
• - With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
• - Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
• - Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.