Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-26 @ 1:22 AM
Study NCT ID:
NCT00626704
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'France', 'Netherlands', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554537', 'term': 'conatumumab'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'dispFirstSubmitDate': '2015-03-24', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2008-02-14', 'dispFirstSubmitQcDate': '2015-03-24', 'studyFirstSubmitQcDate': '2008-02-21', 'dispFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'Length of Study'}], 'secondaryOutcomes': [{'measure': 'Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation.', 'timeFrame': 'Length of Study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'Soft Tissue Sarcoma', 'Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma', 'AMG 655', 'STS', 'Doxorubicin', 'Death receptor', 'TRAIL receptor', 'Apoptosis'], 'conditions': ['Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma', 'Sarcoma', 'Soft Tissue Sarcoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed soft tissue sarcoma\n* Locally advanced, recurrent, or metastatic, unresectable disease\n* Measurable disease according to modified RECIST\n* ECOG performance status of 0 or 1\n* Men or women at least 18 years of age\n* Adequate hematological, renal, hepatic, and coagulation function\n\nExclusion Criteria:\n\n* Prior treatment with anthracyclines\n* Uncontrolled cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00626704', 'briefTitle': 'Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': '20060324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'AMG 655 + Doxorubicin', 'interventionNames': ['Drug: AMG 655', 'Drug: Doxorubicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'Placebo + Doxorubicin', 'interventionNames': ['Other: Placebo', 'Drug: Doxorubicin']}], 'interventions': [{'name': 'AMG 655', 'type': 'DRUG', 'otherNames': ['Conatumumab'], 'description': 'AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inactive dummy AMG 655 (to maintain blind)', 'armGroupLabels': ['Arm 2']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}