Conditions: Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
Keywords: Metastatic Gastric Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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)

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: AZD8931 intervention 2: Placebo intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 40 mg, oral dose twice daily intervention 2: Placebo, oral dose twice daily intervention 3: IV once weekly for 3 weeks followed by a week off.

Protocol document: