Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-02 @ 2:24 AM
Study NCT ID:
NCT00796861
Status:
TERMINATED
Last Update Posted:
2017-12-20
First Post:
2008-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Sunitinib for Refractory Malignant Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'lcream@pennstatehealth.psu.edu', 'phone': '717-531-8870', 'title': 'Dr. Leah Cream', 'organization': 'Penn State Health'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx\n\nSunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Erythematous macular erruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Stenotrophomas (3+) lesion right thigh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Increased creatinine level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Increased aspartate aminotransferase (AST) level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Labial exoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Decreased Albumin level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Increased Hemoglobin count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Decreased white blood cell count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Decreased platelet count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx\n\nSunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).'}], 'timeFrame': 'An average of every 6 weeks', 'description': 'A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analyses were performed as none of the subjects made it through a full cycle.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx\n\nSunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx\n\nSunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Phycisican decided to terminate study due to slow patient accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2008-11-21', 'resultsFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-19', 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.', 'timeFrame': 'An average of every 6 weeks', 'description': 'A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['malignant ascites'], 'conditions': ['Ascites']}, 'descriptionModule': {'briefSummary': 'The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.', 'detailedDescription': 'This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS\\>2).\n* Ascites based on paracentesis or CT scan within one month prior to enrollment\n* Life expectancy \\> 3 months\n* Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion\n* Negative urine pregnancy test for females\n* All subjects must agree to use birth control\n* All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements.\n\nExclusion Criteria:\n\n* History of congestive heart failure\n* Creatinine \\> 2.0\n* Pregnant or nursing\n* ALT \\> 2.5 times the upper limit of normal\n* Blood pressure \\> 160/90 (antihypertensives permitted)\n* Gastrointestinal or intra-abdominal hemorrhage within the last 6 months\n* History of QTc \\> 450 milliseconds\n* Brain metastasis'}, 'identificationModule': {'nctId': 'NCT00796861', 'briefTitle': 'Trial of Sunitinib for Refractory Malignant Ascites', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites', 'orgStudyIdInfo': {'id': 'PSHCI25224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Sunitinib', 'type': 'DRUG', 'otherNames': ['Sunitinib malte'], 'description': 'Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Leah Cream, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not enough valuable data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Leah Cream', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}