Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00070616
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2003-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D052016', 'term': 'Mucositis'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2003-10-06', 'studyFirstSubmitQcDate': '2003-10-07', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation'}], 'secondaryOutcomes': [{'measure': 'To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.'}, {'measure': 'To assess oral mucositis in subjects receiving rHuKGF.'}]}, 'conditionsModule': {'keywords': ['mucositis', 'chemotherapy', 'radiation therapy'], 'conditions': ['Leukemia', 'Lymphoma', 'Myeloma']}, 'referencesModule': {'references': [{'pmid': '17896890', 'type': 'RESULT', 'citation': 'Zia-Amirhosseini P, Hurd DD, Salfi M, Cheah TC, Aycock J, Cesano A. Pharmacokinetics of palifermin administered as the standard dose and as a collapsed dose in patients with hematologic malignancies. Pharmacotherapy. 2007 Oct;27(10):1353-60. doi: 10.1592/phco.27.10.1353.'}], 'seeAlsoLinks': [{'url': 'http://www.kepivance.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': 'Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.', 'detailedDescription': 'Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. Currently, no standard therapy is available to prevent or treat mucositis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma. - Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support."}, 'identificationModule': {'nctId': 'NCT00070616', 'briefTitle': 'Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support', 'nctIdAliases': ['NCT00963170'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': 'An Open-label Study of the Pharmacokinetics (PK) of Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF) in Subjects With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy Followed by Peripheral Blood Progenitor Cell (PBPC) Transplantation', 'orgStudyIdInfo': {'id': '20010182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palifermin 6 x 60 μg/kg/day', 'description': 'The first 3 consecutive daily doses were administered before the initiation of conditioning therapy (study days -11, -10, and -9); 3 additional consecutive daily doses were administered after administration of radiotherapy, chemotherapy and PBPC transplantation (study days 0, 1, and 2).', 'interventionNames': ['Drug: Palifermin 6 x 60 μg/kg/day', 'Radiation: radiotherapy', 'Drug: Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Palifermin 2 x 180 μg/kg/day', 'description': 'The first dose was administered on study day -11, 3 days before the initiation of conditioning therapy, and the second dose was given on day 0 after administration of radiotherapy, chemotherapy and the PBPC infusion', 'interventionNames': ['Drug: Palifermin 2 x 180 μg/kg/day', 'Radiation: radiotherapy', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Palifermin 6 x 60 μg/kg/day', 'type': 'DRUG', 'armGroupLabels': ['Palifermin 6 x 60 μg/kg/day']}, {'name': 'Palifermin 2 x 180 μg/kg/day', 'type': 'DRUG', 'armGroupLabels': ['Palifermin 2 x 180 μg/kg/day']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Palifermin 2 x 180 μg/kg/day', 'Palifermin 6 x 60 μg/kg/day']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'armGroupLabels': ['Palifermin 2 x 180 μg/kg/day', 'Palifermin 6 x 60 μg/kg/day']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}