A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
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|ClinicalTrials.gov Identifier: NCT02015156|
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : April 23, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: PF-05280014 Biological: Herceptin®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||April 2014|
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Other Name: Trastuzumab-Pfizer
|Active Comparator: Trastuzumab-US||
Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Other Name: Trastuzumab-US
- Incidence of body temperature greater than or equal to 38.0 degrees Celsius [ Time Frame: within 24 hours ]
- Incidence of pyrexia [ Time Frame: within 24 hours ]
- Severity of pyrexia [ Time Frame: within 24 hours ]
- Timing of pyrexia [ Time Frame: within 24 hours ]
- Seriousness of pyrexia [ Time Frame: within 24 hours ]
- Relationship of study therapy to pyrexia [ Time Frame: within 24 hours ]
- Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression [ Time Frame: within 24 hours ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Body Mass Index (BMI) of 17.5 to 30.5 kg^m2; and a total body weight >50 kg (110 lbs).
- Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
- 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.
- 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).
- Previous exposure to an anti-HER2 antibody.
- History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015156
|United States, Kansas|
|Pfizer Investigational Site|
|Overland Park, Kansas, United States, 66211|
|Pfizer Investigational Site|
|Overland Park, Kansas, United States, 66212|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||December 19, 2013 Key Record Dates|
|Last Update Posted:||April 23, 2014|
|Last Verified:||April 2014|
Healthy Male Volunteers
Antineoplastic Agents, Immunological