Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 12:17 PM
Study NCT ID:
NCT00719550
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2008-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
Sponsor:
Organization:
Raw JSON
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Cmax and AUC for epirubicin and cisplatin with or without AMG 102', 'timeFrame': '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.'}]}, 'conditionsModule': {'keywords': ['Locally Advanced', 'Metastatic'], 'conditions': ['Esophagogastric Junction Adenocarcinoma', 'Gastric Cancer', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;'}, {'pmid': '24965569', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Oliner K.BM Ph2 Gastric.Journal-004521;'}, {'type': 'BACKGROUND', 'citation': 'TBD.Ph2 Gastric Exposure Response.Journal-004521;'}, {'type': 'BACKGROUND', 'citation': 'TBD.Ph2 Gastric PRO.Journal-004521;'}, {'type': 'BACKGROUND', 'citation': 'Zhu.20060317 ER data.Journal-000728;'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.\n\nPrimary Objective(s):\n\nPart 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.\n\nPart 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* ECOG performance status 0 or 1\n* Male or female ≥ 18 years of age\n\nExclusion Criteria:\n\n* Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma\n* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.\n* Subjects with resectable disease or suitable for definitive chemoradiation\n* Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy\n* Tumors of squamous cell histology\n* Known central nervous system metastases\n* Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization\n* Serious or non-healing wound'}, 'identificationModule': {'nctId': 'NCT00719550', 'briefTitle': 'AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20060317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2 Arm C', 'description': 'AMG 102 placebo plus ECX', 'interventionNames': ['Drug: Capecitabine', 'Drug: Epirubicin', 'Drug: Cisplatin', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Phase 1b', 'description': 'Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Epirubicin', 'Drug: AMG 102', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Arm B', 'description': 'AMG 102 at 7.5mg/kg plus ECX', 'interventionNames': ['Drug: Capecitabine', 'Drug: Epirubicin', 'Drug: AMG 102', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Arm A', 'description': 'AMG 102 at 15mg/kg plus ECX', 'interventionNames': ['Drug: Capecitabine', 'Drug: Epirubicin', 'Drug: AMG 102', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Administered at 625mg/m2 BID orally every day while on study.', 'armGroupLabels': ['Phase 1b', 'Phase 2 Arm A', 'Phase 2 Arm B', 'Phase 2 Arm C']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': 'Administered day 1 of each cycle at 50mg/m2 IV.', 'armGroupLabels': ['Phase 1b', 'Phase 2 Arm A', 'Phase 2 Arm B', 'Phase 2 Arm C']}, {'name': 'AMG 102', 'type': 'DRUG', 'description': 'Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.', 'armGroupLabels': ['Phase 1b', 'Phase 2 Arm A', 'Phase 2 Arm B']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Administered day 1 of each cycle at 60mg/m2 IV.', 'armGroupLabels': ['Phase 1b', 'Phase 2 Arm A', 'Phase 2 Arm B', 'Phase 2 Arm C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution', 'armGroupLabels': ['Phase 2 Arm C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}