AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

Summary

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).

Timeline

Start

2009-02

Primary completion

2010-11

Completion

2013-06

Publications

• Background Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
• Background Iveson T, Donehower RC, Davidenko I, Tjulandin S, Deptala A, Harrison M, Nirni S, Lakshmaiah K, Thomas A, Jiang Y, Zhu M, Tang R, Anderson A, Dubey S, Oliner KS, Loh E. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014 Aug;15(9):1007-18. doi: 10.1016/S1470-2045(14)70023-3. Epub 2014 Jun 22.
• Background Oliner K.BM Ph2 Gastric.Journal-004521;
• Background TBD.Ph2 Gastric Exposure Response.Journal-004521;
• Background TBD.Ph2 Gastric PRO.Journal-004521;
• Background Zhu.20060317 ER data.Journal-000728;

Drugs

Indications