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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01344863




Registration number
NCT01344863
Ethics application status
Date submitted
28/04/2011
Date registered
29/04/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
Scientific title
A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)
Secondary ID [1] 0 0
BO25532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - trastuzumab [Herceptin]
Treatment: Drugs - trastuzumab [Herceptin]

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: trastuzumab [Herceptin]
600 mg subcutaneously using a single-use injection device on Day 1

Treatment: Drugs: trastuzumab [Herceptin]
600 mg subcutaneously using a handheld syringe on Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under plasma concentration curve of trastuzumab
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Maximum observed plasma concentration of trastuzumab
Timepoint [2] 0 0
21 days
Secondary outcome [1] 0 0
Plasma concentration of trastuzumab
Timepoint [1] 0 0
Day 21
Secondary outcome [2] 0 0
Safety: Incidence of adverse events
Timepoint [2] 0 0
21 weeks

Eligibility
Key inclusion criteria
- Healthy male patients, 18 to 45 years of age, inclusive

- No history of hypersensitivity or allergic reactions following drug administration

- No history of clinically significant or clinically relevant cardiac condition

- No history of previous anticancer treatment

- Body mass index (BMI) between 18-32 kg/m2, inclusive
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive test result for drugs of abuse

- Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2

- Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood
pressure greater than 90 mmHG or less than 50 mmHG

- Clinically significant abnormal laboratory values

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, open-label, parallel, 2-arm, multicenter study will compare the
administration of Herceptin (trastuzumab) with a single-use injection device versus a
handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600
mg Herceptin. The anticipated time of the study is 21 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01344863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01344863