AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
Tracking Information
Start Date ICMJE | August 2008 |
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Estimated Primary Completion Date | June 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 History | Complete list of historical versions of study NCT00719550 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 18, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer |
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Official Title ICMJE | 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 |
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 Phase | Phase I, Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 136 | ||||
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Estimated Completion Date | September 2010 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, Greece, Hong Kong, India, Poland, Russian Federation, Singapore, Spain, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00719550 | ||||
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Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study ID Numbers ICMJE | 20060317 | ||||
Study Sponsor ICMJE | Amgen | ||||
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Investigators ICMJE |
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Information Provided By | Amgen | ||||
Verification Date | January 2010 |
Source: http://clinicaltrials.gov/