CompletedPhase 1/2

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

130 participantsStarted 2009-02

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible * ECOG performance status 0 or 1 * Male or female ≥ 18 years of age Exclusion Criteria: * Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy. * Subjects with resectable disease or suitable for definitive chemoradiation * Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy * Tumors of squamous cell histology * Known central nervous system metastases * Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization * Serious or non-healing wound

What they're measuring

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.

Trial details

NCT IDNCT00719550

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-11