An Open-Label, Two-Part, Multi-Centre, Trastuzumab Dose-Finding Study in Healthy Male Volunteers and HER2 Positive Female Patients
Sponsor study identifier
interventional
66
2 countries
3
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram \[mg/kg\] IV in healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants); Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK) parameter values cannot be used to define the target SC dose level. In Part 2 of the study, HER2-positive female participants will receive a single dose of SC Herceptin at the dose level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first (Part 1) dose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 1, 2008
Actual (reported)December 2, 2008
Actual (reported)October 2009
Actual (reported)October 2009
Actual (reported)December 16, 2016
Actual (reported)Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab
AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).
Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab
Day 22
Maximum Observed Serum Concentration of Trastuzumab (Cmax)
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Time to Maximum Serum Concentration (Tmax) of Trastuzumab
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Terminal Elimination Half-Life (T1/2) of Trastuzumab
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1.
Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1.
Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1.
Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.
East Bentleigh, VIC 3165, Australia
Christchurch, 8011, New Zealand
Grafton, 1150, New Zealand
Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B. Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol. 2013 Feb;53(2):192-201. doi: 10.1177/0091270012436560.
Clinical Trials
Hoffmann-La Roche
66 participants (actual enrollment reported by the registry).
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Healthy male participants will receive Herceptin 10 mg/kg SC on Day 1.
Healthy male participants will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohorts 1, 2, 3, and 4.
Female participants with HER2-positive breast cancer will receive Herceptin SC at the dose level determined in Part 1.
Female participants with HER2-positive breast cancer will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohort A.
Contact the study team to confirm eligibility.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
December 16, 2016
Results First Posted
December 16, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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