Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02514603
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608121', 'term': 'prexasertib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)', 'timeFrame': 'Cycle 1 (14 day cycle)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib', 'timeFrame': 'Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)'}, {'measure': 'Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib', 'timeFrame': 'Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)'}, {'measure': 'Percentage of Participants with a Tumor Response', 'timeFrame': 'Baseline to Study Completion (Approximately 24 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neoplasm metastasis', 'Checkpoint Kinase 1', 'CHK1', 'CHK1 inhibitor'], 'conditions': ['Neoplasm']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed\n* Participant must have diagnosis of cancer that is advanced or metastatic\n* Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy\n* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug\n* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding\n\nExclusion Criteria:\n\n* Participant must not have symptomatic central nervous system malignancy or metastasis\n* Participant must not have current hematologic malignancy\n* Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C\n* Participant must not have a serious cardiac condition'}, 'identificationModule': {'nctId': 'NCT02514603', 'briefTitle': 'A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '16018'}, 'secondaryIdInfos': [{'id': 'I4D-JE-JTJK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prexasertib', 'description': 'Prexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met.', 'interventionNames': ['Drug: Prexasertib']}], 'interventions': [{'name': 'Prexasertib', 'type': 'DRUG', 'otherNames': ['LY2606368'], 'description': 'Administered IV', 'armGroupLabels': ['Prexasertib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '277 8577', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '104-0045', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}