Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 12:47 AM
Study NCT ID:
NCT00540332
Status:
WITHDRAWN
Last Update Posted:
2009-03-02
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'France', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051523', 'term': 'Fibroblast Growth Factor 7'}], 'ancestors': [{'id': 'D005346', 'term': 'Fibroblast Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-27', 'studyFirstSubmitDate': '2007-10-04', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent proteinuria', 'timeFrame': '11 weeks'}, {'measure': 'Duration of treatment-emergent proteinuria', 'timeFrame': '11 weeks'}, {'measure': 'Incidence of chronic proteinuria', 'timeFrame': '11 weeks'}, {'measure': 'Time (days) to onset of treatment-emergent proteinuria', 'timeFrame': '11 weeks'}, {'measure': 'Maximum protein-to-creatinine ratio values during the treatment period', 'timeFrame': '11 weeks'}, {'measure': 'Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time', 'timeFrame': 'in Week 1'}], 'secondaryOutcomes': [{'measure': 'Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4', 'timeFrame': '11 weeks'}, {'measure': 'Disease status at End of Treatment visit', 'timeFrame': '11 weeks'}, {'measure': 'Incidence of serum anti-palifermin antibody formation', 'timeFrame': '11 weeks'}, {'measure': 'Incidence of second primary tumors', 'timeFrame': 'up to 10 years (Long-Term Follow-Up phase)'}, {'measure': 'Incidence of other malignancies', 'timeFrame': 'up to 10 years (Long-Term Follow-Up phase)'}, {'measure': 'Progression-free survival', 'timeFrame': 'up to 10 years (Long-Term Follow-Up phase)'}, {'measure': 'Overall survival', 'timeFrame': 'up to 10 years (Long-Term Follow-Up phase)'}, {'measure': 'Incidence of adverse events and laboratory abnormalities', 'timeFrame': '11 weeks'}, {'measure': 'Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4', 'timeFrame': '11 weeks'}]}, 'conditionsModule': {'keywords': ['Oncology', 'KGF', 'HNC', 'head and neck', 'oral mucositis', 'OM', 'proteinurea', 'palifermin', 'clinical trial'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)\n* Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n* Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg\n\nExclusion Criteria:\n\n* Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins\n* Metastatic disease (M1)\n* Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for \\> 3 years\n* History of pancreatitis\n* Prior radiotherapy to the site of disease\n* Prior chemotherapy or requiring chemotherapy during treatment phase of study\n* Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors'}, 'identificationModule': {'nctId': 'NCT00540332', 'briefTitle': 'A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy', 'nctIdAliases': ['NCT00965159'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': 'A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy', 'orgStudyIdInfo': {'id': '20070201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:\n\n* PK cohort will be randomized in a 3:1 ratio \\[palifermin: placebo\\] in at least 12 subjects\n* Non-PK cohort will be randomized in a 1:1 ratio \\[palifermin: placebo\\] in up to 28 subjects.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Palifermin', 'description': 'Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:\n\n* PK cohort will be randomized in a 3:1 ratio \\[palifermin: placebo\\] in at least 12 subjects\n* Non-PK cohort will be randomized in a 1:1 ratio \\[palifermin: placebo\\] in up to 28 subjects.', 'interventionNames': ['Drug: palifermin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.', 'armGroupLabels': ['Placebo']}, {'name': 'palifermin', 'type': 'DRUG', 'description': '120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course', 'armGroupLabels': ['Palifermin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biovitrum AB (publ)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Clinical Development', 'oldOrganization': 'Biovitrum AB (publ)'}}}}