A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

• ClinicalTrials.gov Identifier: NCT02015156
• Recruitment Status: Completed
• First Posted: December 19, 2013
• Last Update Posted: April 23, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02015156
• Other Study ID Numbers: B3271006; REFLECTIONS B327-06
• First Posted: December 19, 2013
• 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:

Trastuzumab; Antineoplastic Agents, Immunological; Antineoplastic Agents