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Completed

NCT Number: NCT00719550

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

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).

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Key information

Conditions

Esophagogastric Junction Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Administered at 625mg/m2 BID orally every day while on study.

Other names: Xeloda

Epirubicin

Drug

Administered day 1 of each cycle at 50mg/m2 IV.

AMG 102

Drug

Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.

Cisplatin

Drug

Administered day 1 of each cycle at 60mg/m2 IV.

Placebo

Drug

AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution

Primary outcomes

  1. Progression free survival (PFS), as measured by RECIST per local review

    Time frame: 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.

Secondary outcomes

  1. Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).

    Time frame: 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.

  2. Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation.

    Time frame: 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.

  3. Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Jul 21, 2008
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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