Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01013818
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2009-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Terminated due to slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, frequency and severity of adverse events', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Measure pharmacokinetic profile', 'timeFrame': '1st two months of the study'}, {'measure': 'Evaluation of pharmacodynamics', 'timeFrame': '1st two months of the study'}, {'measure': 'Evaluation of possible anti-tumor activity', 'timeFrame': 'Every 2 months while on study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoid Malignancies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed relapsed/refractory lymphoid malignancies\n* Previously treated with at least 2 therapeutic regimens\n* ECOG performance \\< 2.\n* Life expectancy of at least 3 months\n* Adequate renal function\n* Adequate hematologic status\n* Adequate liver function\n* Transfusion independent\n\nExclusion Criteria:\n\n* Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity\n* The use of systemic corticosteroids within 1 week of starting treatment with HGS1029\n* Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029\n* Known HIV infection\n* Positive for hepatitis B surface antigen or positive hepatitis C antibody\n* Grade 2 or greater neuropathy\n* Pregnant female or nursing mother\n* Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029'}, 'identificationModule': {'nctId': 'NCT01013818', 'briefTitle': 'A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Genome Sciences Inc.'}, 'officialTitle': 'A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies', 'orgStudyIdInfo': {'id': 'HGS1029-C1080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HGS1029', 'interventionNames': ['Drug: HGS1029']}], 'interventions': [{'name': 'HGS1029', 'type': 'DRUG', 'description': 'HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.', 'armGroupLabels': ['HGS1029']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': 'OX3 7LJ', 'city': 'Headington', 'state': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Cancer and Haematology Centre', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}, {'zip': 'SM2 5NG', 'city': 'Belmont, Sutton, Surrey', 'country': 'United Kingdom', 'facility': 'The Institute of Cancer Research'}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Cancer Research UK Centre', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Genome Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}