AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
NCT ID: NCT00719550
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2009-02-28
2013-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 2 Arm C
AMG 102 placebo plus ECX
Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Placebo
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
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.
Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Interventions
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Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Placebo
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0 or 1
* Male or female ≥ 18 years of age
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
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.
Oliner K.BM Ph2 Gastric.Journal-004521;
TBD.Ph2 Gastric Exposure Response.Journal-004521;
TBD.Ph2 Gastric PRO.Journal-004521;
Zhu.20060317 ER data.Journal-000728;
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060317
Identifier Type: -
Identifier Source: org_study_id