Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT02016534
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609912', 'term': 'AMG 337'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Amgen decision following interim review of efficacy and safety data from the AMG 337 program.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2017-06-28', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2013-12-16', 'dispFirstSubmitQcDate': '2017-06-28', 'studyFirstSubmitQcDate': '2013-12-16', 'dispFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Reported Outcomes (PRO) Health related quality of life (HRQoL)', 'timeFrame': '3 years', 'description': 'To evaluate the impact of AMG 337 on health-related quality of life (HRQoL) in subjects with MET amplified G/GEJ/E adenocarcinoma (Cohort 1 only).'}, {'measure': 'Tumor tissue and circulating serum biomarkers', 'timeFrame': '3 years', 'description': 'assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment'}, {'measure': 'Prediction of response rates to AMG 337 by analysing tumor DNA for MET pathway-related genes', 'timeFrame': '3 years', 'description': 'To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337'}, {'measure': 'Response to AMG 337 and MET amplification, expression or presence of mutation in tumor specimens', 'timeFrame': '3 years', 'description': 'Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337.'}], 'primaryOutcomes': [{'measure': 'Objective Response Rate (RECIST v1.1) in subjects with MET Amplified measurable G/GEJ/E adenocarcinoma (Cohort 1)', 'timeFrame': '2.5 years', 'description': 'Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma'}], 'secondaryOutcomes': [{'measure': 'Duration of response (cohort 1 and subjects with measurable disease at baseline in cohort 2)', 'timeFrame': '2.5 years'}, {'measure': 'Time to response (Cohort 1 and subjects with measurable disease at baseline in cohort 2)', 'timeFrame': '2.5 years'}, {'measure': 'Progression free survival', 'timeFrame': '2.5 years'}, {'measure': 'Overall survival', 'timeFrame': '2.5 years'}, {'measure': 'Incidence and severity of adverse events and significant laboratory abnormalities', 'timeFrame': '2.5 years'}, {'measure': 'AMG 337 exposure and dose intensity', 'timeFrame': '2.5 years'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': '2.5 years', 'description': 'Including, but not limited to, minimum (trough) concentrations at pre-dose times, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration - time curve (AUC).'}, {'measure': 'Objective Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2).', 'timeFrame': '2.5 years', 'description': 'Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MET Amplified Gastric / Gastroesophageal Junction / Esophageal Adenocarcinoma, or other solid tumors.'], 'conditions': ['Stomach Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.', 'detailedDescription': 'This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.\n\nTumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.\n\nTumor assessment by RECIST 1.1 will be followed during study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to daily self-administer AMG 337 orally as a whole capsule\n* Male or female 18 years of age or over.\n* Pathologically confirmed advanced G/GEJ/E adenocarcinoma (Cohort 1) or other solid tumor (Cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy\n* Tumor MET amplified by protocol-specified centralized testing.\n* Measurable disease per RECIST 1.1 guidelines. Cohort 2 may include up to 10 subjects with advanced MET amplified, G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1\n* (ECOG) Performance Status of 0, 1 or 2\n\nExclusion Criteria:\n\n* Known central nervous system metastases\n* Candidate for curative surgery or definitive chemoradiation\n* Peripheral edema \\> grade 1\n* Persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption\n* Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety\n* Detectable Hepatitis C virus (indicative of active Hepatitis C)\n* Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment\n* Prior treatment with small molecule inhibitors of the MET pathway.\n\nOther protocol defined inclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02016534', 'briefTitle': 'Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors', 'orgStudyIdInfo': {'id': '20130111'}, 'secondaryIdInfos': [{'id': '2013-001277-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'AMG 337 Monotherapy', 'interventionNames': ['Drug: AMG 337']}], 'interventions': [{'name': 'AMG 337', 'type': 'DRUG', 'description': 'AMG 337 300mg orally daily.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 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