Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 7:06 PM
Study NCT ID:
NCT00105092
Status:
COMPLETED
Last Update Posted:
2007-05-01
First Post:
2005-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C504878', 'term': 'enzastaurin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-27', 'studyFirstSubmitDate': '2005-03-04', 'studyFirstSubmitQcDate': '2005-03-04', 'lastUpdatePostDateStruct': {'date': '2007-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the rate of progression-free survival at 6 months for patients receiving oral enzastaurin with NSCLC who are eligible for second-or third-line therapy'}], 'secondaryOutcomes': [{'measure': 'To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population'}, {'measure': 'To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)'}, {'measure': 'To estimate the objective response rate (complete response [CR] and partial response [PR])'}, {'measure': 'To estimate time-to-event variables, such as overall survival time, duration of overall response (up to 1 year), and duration of stable disease (up to 1 year)'}, {'measure': 'To evaluate the safety of enzastaurin in this patient population'}, {'measure': 'To assess PKCb expression by immunohistochemistry in readily available tumors from patients'}, {'measure': "To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires"}, {'measure': 'To explore biomarkers relevant to tumor progression and PKCb signaling'}]}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be at least 18 years old\n* Must have been diagnosed with advanced or metastatic non-small cell lung cancer\n* Must be able to visit the doctor's office every 28 days for 6 months or longer.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Have other significant medical problems as determined by your physician\n* Are unable to swallow tablets\n* Have a history of significant heart disease"}, 'identificationModule': {'nctId': 'NCT00105092', 'briefTitle': 'Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '8670'}, 'secondaryIdInfos': [{'id': 'H6Q-MC-JCAQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Enzastaurin HCL', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampa', 'state': 'Florida', 'country': 'United States', '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': 27.94752, 'lon': -82.45843}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', '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': 36.16589, 'lon': -86.78444}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', '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': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 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'}}}}