Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-02 @ 4:00 PM
Study NCT ID:
NCT01179295
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2010-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese BAY86-9766 Monotherapy Phase I Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C544830', 'term': 'N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2012-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.', 'timeFrame': 'At the end of 30-day follow up after discontinuation of study drug administration'}, {'measure': 'Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).', 'timeFrame': 'Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'On average 3 months'}, {'measure': 'Disease control rate', 'timeFrame': 'On average 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MEK inhibitor', 'BAY86-9766', 'RDEA 119', 'Solid tumor'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.\n* Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)\n* At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1\n* Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication\n* Uncontrolled hypertension defined as systolic blood pressure \\> 150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management\n* Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C\n* Inadequate bone marrow, liver and renal function\n* Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs\n* Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers'}, 'identificationModule': {'nctId': 'NCT01179295', 'briefTitle': 'Japanese BAY86-9766 Monotherapy Phase I Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors', 'orgStudyIdInfo': {'id': '15091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: BAY86-9766']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: BAY86-9766']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: BAY86-9766']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'interventionNames': ['Drug: BAY86-9766']}], 'interventions': [{'name': 'BAY86-9766', 'type': 'DRUG', 'description': 'BAY86-9766 30 mg twice a day (bid).', 'armGroupLabels': ['Arm 1']}, {'name': 'BAY86-9766', 'type': 'DRUG', 'description': 'BAY86-9766 50 mg twice a day (bid).', 'armGroupLabels': ['Arm 2']}, {'name': 'BAY86-9766', 'type': 'DRUG', 'description': 'BAY86-9766 100 mg once a day (od)', 'armGroupLabels': ['Arm 3']}, {'name': 'BAY86-9766', 'type': 'DRUG', 'description': 'BAY86-9766 60 mg once a day (od)', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}