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


Tracking Information

Start Date  ICMJEAugust 2008
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 26, 2008)		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. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: July 18, 2008)		Progression free survival. [ 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. ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00719550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 18, 2008)
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEAMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
Official Title  ICMJEA 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
Brief 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).

Detailed Description 
Study PhasePhase I, Phase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Esophagogastric Junction Adenocarcinoma
  • Gastric Cancer
  • Esophageal Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    Administered at 625mg/m2 BID orally every day while on study.
    Other Name: Xeloda
  • Drug: Epirubicin
    Administered day 1 of each cycle at 50mg/m2 IV.
  • Drug: AMG 102
    Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
  • Drug: Cisplatin
    Administered day 1 of each cycle at 60mg/m2 IV.
Study Arms / Comparison Groups
  • Phase 2 Arm C: Placebo Comparator
    AMG 102 placebo plus ECX
    Interventions:
    • Drug: Capecitabine
    • Drug: Epirubicin
    • Drug: Cisplatin
  • Phase 1b
    Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
    Interventions:
    • Drug: Capecitabine
    • Drug: Epirubicin
    • Drug: AMG 102
    • Drug: Cisplatin
  • Phase 2 Arm B: Active Comparator
    AMG 102 at 7.5mg/kg plus ECX
    Interventions:
    • Drug: Capecitabine
    • Drug: Epirubicin
    • Drug: AMG 102
    • Drug: Cisplatin
  • Phase 2 Arm A: Active Comparator
    AMG 102 at 15mg/kg plus ECX
    Interventions:
    • Drug: Capecitabine
    • Drug: Epirubicin
    • Drug: AMG 102
    • Drug: Cisplatin

Recruitment Information

Estimated Enrollment  ICMJE136
Estimated Completion DateSeptember 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Canada,   Greece,   Hong Kong,   India,   Poland,   Russian Federation,   Singapore,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00719550
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20060317
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen
Verification DateJanuary 2010