Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 6:40 PM
Study NCT ID:
NCT00757757
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2008-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2013-02-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-09-21', 'dispFirstSubmitQcDate': '2013-02-09', 'studyFirstSubmitQcDate': '2008-09-22', 'dispFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase', 'timeFrame': 'every cycle - (cycle = 28 days)'}, {'measure': 'Type and frequency of adverse drug reactions and serious adverse drug reactions', 'timeFrame': 'every cycle - (cycle = 28 days)'}], 'secondaryOutcomes': [{'measure': 'Change in markers of bone resorption and formation (pre- vs. post-treatment)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'bone metastases', 'anti-M-CSF', 'M-CSF antibody', 'M-CSF', 'Prostate Cancer with bone metastases'], 'conditions': ['Prostate Cancer', 'Bone Metastases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4613', 'label': 'Results for CMCS110A2101 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment\n* 18 years old and over\n\nExclusion Criteria:\n\n* Plan to be on cytotoxic or biologic therapy during study\n* Active dental problems\n* Active heart complications\n* Active infection\n* Patients with moderate to severe swelling due to fluid\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00757757', 'briefTitle': 'A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases', 'orgStudyIdInfo': {'id': 'CMCS110A2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCS110', 'interventionNames': ['Drug: MCS110']}], 'interventions': [{'name': 'MCS110', 'type': 'DRUG', 'description': 'Anti-M-CSF antibody', 'armGroupLabels': ['MCS110']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'NV Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CTRC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}