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

Primary Purpose

Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Capecitabine
Epirubicin
AMG 102
Cisplatin
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagogastric Junction Adenocarcinoma focused on measuring Locally Advanced, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Other

    Active Comparator

    Active Comparator

    Arm Label

    Phase 2 Arm C

    Phase 1b

    Phase 2 Arm B

    Phase 2 Arm A

    Arm Description

    AMG 102 placebo plus ECX

    Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.

    AMG 102 at 7.5mg/kg plus ECX

    AMG 102 at 15mg/kg plus ECX

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).
    Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation.
    Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102

    Full Information

    First Posted
    July 17, 2008
    Last Updated
    November 13, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00719550
    Brief Title
    AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer
    Keywords
    Locally Advanced, Metastatic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 2 Arm C
    Arm Type
    Placebo Comparator
    Arm Description
    AMG 102 placebo plus ECX
    Arm Title
    Phase 1b
    Arm Type
    Other
    Arm Description
    Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
    Arm Title
    Phase 2 Arm B
    Arm Type
    Active Comparator
    Arm Description
    AMG 102 at 7.5mg/kg plus ECX
    Arm Title
    Phase 2 Arm A
    Arm Type
    Active Comparator
    Arm Description
    AMG 102 at 15mg/kg plus ECX
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Other Intervention Name(s)
    Xeloda
    Intervention Description
    Administered at 625mg/m2 BID orally every day while on study.
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin
    Intervention Description
    Administered day 1 of each cycle at 50mg/m2 IV.
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 102
    Intervention Description
    Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Administered day 1 of each cycle at 60mg/m2 IV.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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.
    Title
    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.
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
    Results Reference
    background
    PubMed Identifier
    24965569
    Citation
    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.
    Results Reference
    background
    Citation
    Oliner K.BM Ph2 Gastric.Journal-004521;
    Results Reference
    background
    Citation
    TBD.Ph2 Gastric Exposure Response.Journal-004521;
    Results Reference
    background
    Citation
    TBD.Ph2 Gastric PRO.Journal-004521;
    Results Reference
    background
    Citation
    Zhu.20060317 ER data.Journal-000728;
    Results Reference
    background
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

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

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