J1280, A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
This study will see if there is benefit in adding rilotumumab to a standard chemotherapy regimen (ECX) compared with chemotherapy alone and whether the combination of rilotumumab and standard chemotherapy (ECX) causes any side effects. To do this, rilotumumab will be compared to placebo.
Inclusion Criteria 1. Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma; adenocarcinomas of the distal esophagus within 5 cm of the GEJ are eligible 2. ECOG performance status (0 or 1) 3. Tumor MET-positive by IHC (fulfilling the MET IHC criteria as defined by an investigational use only MET IHC assay) by protocol-specified centralized testing 4. Formalin fixed paraffin-embedded (FFPE) tumor tissue submission required 5. Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria 6. Men or women greater than or equal to 18 years of age 7. Before any study-specific procedure, the appropriate written informed consent must be obtained 8. Adequate organ function / lab values as defined in protocol 9. Able to tolerate infusions and take oral medications
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. Approximately 450 subjects (5 at Johns Hopkins) will be randomized in a 1:1 ratio to either: Arm 1: Rilotumumab plus ECX, Q21 days (Â± 3 days) Arm 2: Rilotumumab-placebo plus ECX, Q21 days (Â± 3 days)
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