Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-24 @ 9:12 PM
Study NCT ID:
NCT02015156
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598430', 'term': 'PF-05280014'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of body temperature greater than or equal to 38.0 degrees Celsius', 'timeFrame': 'within 24 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of pyrexia', 'timeFrame': 'within 24 hours'}, {'measure': 'Severity of pyrexia', 'timeFrame': 'within 24 hours'}, {'measure': 'Timing of pyrexia', 'timeFrame': 'within 24 hours'}, {'measure': 'Seriousness of pyrexia', 'timeFrame': 'within 24 hours'}, {'measure': 'Relationship of study therapy to pyrexia', 'timeFrame': 'within 24 hours'}, {'measure': 'Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression', 'timeFrame': 'within 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trastuzumab', 'Healthy Male Volunteers', 'Single-Dose', 'Phase 1', 'Biosimilarity'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3271006&StudyName=A%20Study%20Evaluating%20The%20Safety%20Of%20PF-05280014%20And%20Trastuzumab%20In%20Healthy%20Male%20Volunteers%20%28REFLECTIONS%20B327-06%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.', 'detailedDescription': 'Safety evaluation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) of 17.5 to 30.5 kg\\^m2; and a total body weight \\>50 kg (110 lbs).\n* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.\n* Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Previous exposure to an anti-HER2 antibody.\n* History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.'}, 'identificationModule': {'nctId': 'NCT02015156', 'briefTitle': 'A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'B3271006'}, 'secondaryIdInfos': [{'id': 'REFLECTIONS B327-06'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-05280014', 'interventionNames': ['Biological: PF-05280014']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trastuzumab-US', 'interventionNames': ['Biological: Herceptin®']}], 'interventions': [{'name': 'PF-05280014', 'type': 'BIOLOGICAL', 'otherNames': ['Trastuzumab-Pfizer'], 'description': 'Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1', 'armGroupLabels': ['PF-05280014']}, {'name': 'Herceptin®', 'type': 'BIOLOGICAL', 'otherNames': ['Trastuzumab-US'], 'description': 'Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1', 'armGroupLabels': ['Trastuzumab-US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}