Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00400569
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2006-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alberto.chiappori@moffitt.org', 'phone': '813-745-2158', 'title': 'Alberto Chiappori, M.D.', 'organization': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial was amended to exclude fibrosarcoma after only one patient was accrued while the other cohorts had completed 75% or more of their planned accrual. Only patients with liposarcoma, leiomyosarcoma, or MFH were enrolled after this amendment.'}}, 'adverseEventsModule': {'timeFrame': '4 years, 7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks', 'otherNumAtRisk': 48, 'otherNumAffected': 39, 'seriousNumAtRisk': 48, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 44, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 30, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Hemorrhage/bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 27, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}], 'seriousEvents': [{'term': 'Liver dysfunction/failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Pain - Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Death not associated with CTCAE term - Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Infection with unknown ANC - Peritoneal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Cardiac general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Hemorrhate/Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC V3'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assessable for response'}, {'type': 'SECONDARY', 'title': "Participants' Progression Free Survival (PFS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}, {'id': 'OG001', 'title': 'Leiomyosarcoma Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}, {'id': 'OG002', 'title': 'Malignant Fibrous Histiocytoma (MFH) Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.4'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.3'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}, {'type': 'SECONDARY', 'title': "Participants' Overall Survival (OS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}, {'id': 'OG001', 'title': 'Leiomyosarcoma Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}, {'id': 'OG002', 'title': 'Malignant Fibrous Histiocytoma (MFH) Cohort Only', 'description': 'Experimental: Sunitinib Malate (SU011248) Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '27.7'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '11.9'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '36.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years, 7 months', 'description': 'Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'From September 2006 to August 2007, a total of 48 patients were enrolled on the study by the Moffitt Cancer Center Sarcoma Program. In general, the patients had been heavily pretreated previously, with a significant number receiving more than one prior chemotherapy regimen and most with multiple metastatic sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2006-11-15', 'resultsFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2006-11-16', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-25', 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Overall Response (OR)', 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).'}], 'secondaryOutcomes': [{'measure': "Participants' Progression Free Survival (PFS)", 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).'}, {'measure': "Participants' Overall Survival (OS)", 'timeFrame': 'From On Treatment to Off Study - average of 6 months', 'description': 'The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': '4 years, 7 months', 'description': 'Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sunitinib malate', 'SUTENT', 'SU011248', 'Soft tissue sarcoma', 'Gastrointestinal stromal tumors (GIST)', 'MFH', 'Tyrosine kinase inhibitor', 'Imatinib mesylate', 'Phase II'], 'conditions': ['Liposarcoma', 'Leiomyosarcoma', 'Fibrosarcoma', 'Malignant Fibrous Histiocytoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.moffitt.org/', 'label': 'Moffitt Cancer Center Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.\n\nAll patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.', 'detailedDescription': 'This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.\n\nAll patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.\n\nAn office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.\n* Adequate organ function as defined by the following criteria:\n\n * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy\n * Total serum bilirubin less than or equal to 1.5 x ULN\n * Absolute neutrophil count (ANC) greater than or equal to1500/microL\n * Platelets greater than or equal to 100,000/microL\n * Hemoglobin greater than or equal to 9.0 g/dL\n * Serum calcium less than or equal to 12.0 mg/dL\n * Serum creatinine less than or equal to 1.5 x ULN\n* Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH\n* Measurable disease radiographically\n* Disease that is deemed surgically unresectable and/or metastatic\n* Age greater than or equal to 18 years\n* Life expectancy greater than 16 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n* Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment.\n\nExclusion Criteria:\n\n* Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.\n* NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.\n* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.\n* Any of the following within the 6 months prior to study drug administration:\n\n * myocardial infarction,\n * severe/unstable angina,\n * coronary/peripheral artery bypass graft,\n * symptomatic congestive heart failure,\n * cerebrovascular accident or transient ischemic attack, or pulmonary embolism\n* Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2\n* Prolonged QTc interval on baseline electrocardiogram (ECG) \\> 500 msec.\n* Hypertension that cannot be controlled by medications (\\>150/100 mm Hg despite optimal medical therapy)\n* Prior tyrosine kinase inhibitor therapy\n* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication\n* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection\n* Concurrent treatment on another clinical trial, except supportive care or non-treatment trials\n* Concomitant use of agents known to induce or inhibit CYP3A4\n* Concomitant use of agents metabolized by the cytochrome P450 system\n* Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth \\[PO\\] daily for thrombo-prophylaxis is allowed)\n* Pregnancy or breastfeeding patients\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.'}, 'identificationModule': {'nctId': 'NCT00400569', 'briefTitle': 'Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'MCC-14902'}, 'secondaryIdInfos': [{'id': 'GA618075', 'type': 'OTHER', 'domain': 'Pfizer Pharamaceutic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunitinib Malate (SU011248) Treatment', 'description': 'Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks', 'interventionNames': ['Drug: Sunitinib Malate (SU011248)']}], 'interventions': [{'name': 'Sunitinib Malate (SU011248)', 'type': 'DRUG', 'otherNames': ['Sutent', 'SU011248'], 'description': 'For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.', 'armGroupLabels': ['Sunitinib Malate (SU011248) Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Alberto Chiappori, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}