AMG 102 plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
Study Details
Study Phase: 1b/2
Indication: Previously untreated subjects with unresectable locally advanced or metastatic
gastric or esophagogastric junction adenocarcinoma.
Primary Objective(s):
Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.
Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).
Protocol Summary
Progression free survival (PFS), as measured by RECIST per local review
Timeframe: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.
Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).
Timeframe: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.
Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation.
Timeframe: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.
Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102
Timeframe: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.