Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 6:56 PM
Study NCT ID:
NCT01733004
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'C564816', 'term': 'Insulin-Like Growth Factor I, Resistance To'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595155', 'term': 'Istiratumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity and number of adverse events related to escalating doses of MM-141', 'timeFrame': '2 years', 'description': 'Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Hepatocellular Carcinoma', 'Oncology', 'Phase I', 'ErbB3', 'IGF-1R', 'Everolimus', 'Gemcitabine', 'Abraxane'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy\n* Eighteen years of age or above\n* Able to understand and sign an informed consent (or have a legal representative who is able to do so)\n* Measurable disease according to RECIST v1.1\n* ECOG Performance Score of 0 or 1\n* Adequate bone marrow, hepatic, renal and cardiac function\n* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141\n\nExclusion Criteria:\n\n* Active infection or fever \\> 38.5°C during screening visits or on the first scheduled day of dosing\n* Symptomatic CNS disease\n* Received other recent antitumor therapy\n* Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01733004', 'briefTitle': 'A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merrimack Pharmaceuticals'}, 'officialTitle': 'A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'MM-141-01-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'MM-141 monotherapy', 'interventionNames': ['Drug: MM-141']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'MM-141 and Everolimus', 'interventionNames': ['Drug: MM-141']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'MM-141 and Abraxane and Gemcitabine', 'interventionNames': ['Drug: MM-141']}], 'interventions': [{'name': 'MM-141', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Chrystal Louis, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merrimack Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merrimack Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}