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A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females

NCT ID: NCT00800436

Last Updated: 2016-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Cohort 1

Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 1: Cohort 2

Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 1: Cohort 3

Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 1: Cohort 4

Healthy male participants will receive Herceptin 10 mg/kg SC on Day 1.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 1: Cohort 5

Healthy male participants will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohorts 1, 2, 3, and 4.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 2: Cohort A

Female participants with HER2-positive breast cancer will receive Herceptin SC at the dose level determined in Part 1.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Part 2: Cohort B

Female participants with HER2-positive breast cancer will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohort A.

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Interventions

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Herceptin

Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.

Intervention Type DRUG

Other Intervention Names

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Trastuzumab

Eligibility Criteria

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Inclusion Criteria

* Healthy Participants (Part 1 only)

* Males 18 to 45 to years of age
* Baseline left ventricular ejection fraction (LVEF) greater than (\>) 60 percent (%)
* HER2-Positive Females (Parts 1 and 2)

* Females greater than or equal to (≥) 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0
* Previous non-metastatic operable primary invasive HER2-positive breast cancer
* Baseline LVEF \>55%

Exclusion Criteria

* Healthy Participants (Part 1 only)

* Clinically significant abnormalities in laboratory test results or electrocardiogram
* History of significant allergies, gastrointestinal, renal, hepatic, cardiovascular, or pulmonary disease
* History of hypersensitivity or allergic reaction, spontaneous or following drug administration
* History of cardiac conditions
* HER2-Positive Females (Parts 1 and 2)

* Metastatic disease
* Concurrent other malignancy requiring therapy of any modality which may interfere with PK investigations or result in unexpected toxicity
* Use of Herceptin in previous 5 months
* Serious cardiac illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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East Bentleigh, , Australia

Site Status

Christchurch, , New Zealand

Site Status

Grafton, , New Zealand

Site Status

Countries

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Australia New Zealand

References

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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.

Reference Type DERIVED
PMID: 23436264 (View on PubMed)

Other Identifiers

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BP22023

Identifier Type: -

Identifier Source: org_study_id