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Trial record 1 of 27 for:    PF-05280014
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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: PF-05280014 Biological: Herceptin® Phase 1

Detailed Description:
Safety evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: PF-05280014 Biological: PF-05280014
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 Biological: Herceptin®
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




Primary Outcome Measures :
  1. Incidence of body temperature greater than or equal to 38.0 degrees Celsius [ Time Frame: within 24 hours ]

Secondary Outcome Measures :
  1. Incidence of pyrexia [ Time Frame: within 24 hours ]
  2. Severity of pyrexia [ Time Frame: within 24 hours ]
  3. Timing of pyrexia [ Time Frame: within 24 hours ]
  4. Seriousness of pyrexia [ Time Frame: within 24 hours ]
  5. Relationship of study therapy to pyrexia [ Time Frame: within 24 hours ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02015156     History of Changes
Other Study ID Numbers: B3271006
REFLECTIONS B327-06
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Pfizer:
Trastuzumab
Healthy Male Volunteers
Single-Dose
Phase 1
Biosimilarity

Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents