Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00921869
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2009-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548173', 'term': "N-(2-fluoro-4-((2-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)carbonylaminopyridin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)', 'timeFrame': 'During the Run-in Phase and the first 5 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Dose-limiting toxicities.', 'timeFrame': 'During the Run-in Phase and the first 5 weeks of treatment'}, {'measure': 'Incidence and severity of adverse events and their drug relationship.', 'timeFrame': 'Throughout the entire study'}, {'measure': 'PK of blood and urine', 'timeFrame': 'During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine'}, {'measure': 'Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples.', 'timeFrame': 'During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies'}, {'measure': 'Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors.', 'timeFrame': 'Every 4 weeks for complete and partial response; by 7th week for stable disease'}]}, 'conditionsModule': {'keywords': ['Cancer', 'Gastrointestinal Cancer'], 'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.', 'detailedDescription': 'Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.\n2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.\n3. Subjects with adequate organ function.\n4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.\n5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).\n\nExclusion criteria:\n\n1. Subjects who have brain metastases with clinical symptoms or which requires treatment.\n2. Subjects with the serious complications or disease history.\n3. Subjects who cannot take oral medication.\n4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.\n5. Female subjects who are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00921869', 'briefTitle': 'A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'E7050-J081-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: E7050']}], 'interventions': [{'name': 'E7050', 'type': 'DRUG', 'description': 'The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Takashi Sawada', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}