Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-04 @ 5:21 AM
Study NCT ID:
NCT01610050
Status:
COMPLETED
Last Update Posted:
2014-11-11
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of LFA102 in Japanese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C583731', 'term': 'LFA102 monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-09', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities (DLT)', 'timeFrame': '1st treatment cycle (28 days)', 'description': 'Frequency and severity of dose limiting toxicities (DLTs)'}], 'secondaryOutcomes': [{'measure': 'Frequency, duration and severity of Adverse Events (AEs)', 'timeFrame': 'at informed consent, until 28 days after treatment discontinuation', 'description': 'Frequency, duration and severity of all AEs will be collected.'}, {'measure': 'Serum Concentration', 'timeFrame': 'cycle 1 day 1 until disease progression'}, {'measure': 'Objective Response Rate', 'timeFrame': 'every 8 week or 12 weeks, until disase progression', 'description': 'Assessed based on RECIST/PCWG2 criteria'}, {'measure': 'Antibodies against LFA102', 'timeFrame': 'day 1 of each treatment cycle until disease progression', 'description': 'Serum concentration of antibodies against LFA102'}, {'measure': 'Progression Free Survival', 'timeFrame': 'every 8 or 12 weeks until disease progression', 'description': 'Assessed based on RECIST/PCWG2 criteria'}, {'measure': 'PK parameters', 'timeFrame': 'cycle 1 day 1 until disease progression', 'description': 'Cmax, Tmax, AUC, T1/2, CL and V'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['castration-resistant prostate cancer, advanced breast cancer'], 'conditions': ['Castration-resistant Prostate Cancer, Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate safety and tolerability to determine the MTD/RD.', 'detailedDescription': 'This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.\n\nThis study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of prostate cancer\n* Histologically or cytologically confirmed locally advanced or metastatic breast cancer\n\nExclusion Criteria:\n\n* Patients with untreated and/or symptomatic metastatic CNS disease\n* Prior anaphylactic or other severe infusion reaction\n* Treatment with agent which affect prolactin levels\n* Active autoimmune disease\n\nOther protcol-defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01610050', 'briefTitle': 'A Phase I Study of LFA102 in Japanese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CLFA102X1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LFA102', 'interventionNames': ['Drug: LFA102']}], 'interventions': [{'name': 'LFA102', 'type': 'DRUG', 'otherNames': ['anti prolactin receptor humanized monoclonal antibody'], 'armGroupLabels': ['LFA102']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}