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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05275010




Registration number
NCT05275010
Ethics application status
Date submitted
2/03/2022
Date registered
11/03/2022

Titles & IDs
Public title
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
Scientific title
A Randomized, Open-Label, 2-Arm, Parallel Group, Single Dose, Multi-Centre Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
Secondary ID [1] 0 0
WP42873
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)
Treatment: Devices - Handheld Syringe with Hypodermic Needle
Treatment: Devices - On-Body Delivery System

Active comparator: Arm 1: PH FDC SC Administered Using a Handheld Syringe with Hypodermic Needle -

Experimental: Arm 2: PH FDC SC Administered Using the On-Body Delivery System -


Treatment: Drugs: Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).

Treatment: Devices: Handheld Syringe with Hypodermic Needle
A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using a handheld manual syringe.

Treatment: Devices: On-Body Delivery System
A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using the on-body delivery system.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Time-Concentration Curve from the Start of Dosing to 63 Days (AUC0-62) of Serum Pertuzumab
Timepoint [1] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Primary outcome [2] 0 0
Area Under the Time-Concentration Curve from the Start of Dosing to 63 Days (AUC0-62) of Serum Trastuzumab
Timepoint [2] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Primary outcome [3] 0 0
Maximum Serum Concentration (Cmax) of Pertuzumab
Timepoint [3] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Primary outcome [4] 0 0
Maximum Serum Concentration (Cmax) of Trastuzumab
Timepoint [4] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [1] 0 0
Observed Serum Concentration of Pertuzumab on Day 22
Timepoint [1] 0 0
Day 22
Secondary outcome [2] 0 0
Observed Serum Concentration of Trastuzumab on Day 22
Timepoint [2] 0 0
Day 22
Secondary outcome [3] 0 0
Observed Serum Concentration of Pertuzumab on Day 63
Timepoint [3] 0 0
Day 63
Secondary outcome [4] 0 0
Observed Serum Concentration of Trastuzumab on Day 63
Timepoint [4] 0 0
Day 63
Secondary outcome [5] 0 0
Area Under the Time-Concentration Curve from the Start of Dosing Extrapolated to Infinity (AUC0-8) of Serum Pertuzumab
Timepoint [5] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [6] 0 0
Area Under the Time-Concentration Curve from the Start of Dosing Extrapolated to Infinity (AUC0-8) of Serum Trastuzumab
Timepoint [6] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [7] 0 0
Observed Time to Maximum Serum Concentration (tmax) of Pertuzumab
Timepoint [7] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [8] 0 0
Observed Time to Maximum Serum Concentration (tmax) of Trastuzumab
Timepoint [8] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [9] 0 0
Terminal Elimination Half-Life (t1/2) of Pertuzumab
Timepoint [9] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [10] 0 0
Terminal Elimination Half-Life (t1/2) of Trastuzumab
Timepoint [10] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [11] 0 0
Apparent Drug Clearance (CL/F) of Pertuzumab
Timepoint [11] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [12] 0 0
Apparent Drug Clearance (CL/F) of Trastuzumab
Timepoint [12] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [13] 0 0
Apparent Volume of Distribution (Vd/F) of Pertuzumab
Timepoint [13] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [14] 0 0
Apparent Volume of Distribution (Vd/F) of Trastuzumab
Timepoint [14] 0 0
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Secondary outcome [15] 0 0
Summary of the Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Timepoint [15] 0 0
From informed consent until safety follow-up visit (up to 7 months)
Secondary outcome [16] 0 0
Change from Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Timepoint [16] 0 0
Baseline, once between Days 20 and 35, and once between Days 56 and 63
Secondary outcome [17] 0 0
Change from Baseline Respiratory Rate Over Time
Timepoint [17] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [18] 0 0
Change from Baseline Pulse Rate Over Time
Timepoint [18] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [19] 0 0
Change from Baseline Body Temperature Over Time
Timepoint [19] 0 0
Baseline, Days 1 and 63
Secondary outcome [20] 0 0
Change from Baseline Systolic Blood Pressure Over Time
Timepoint [20] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [21] 0 0
Change from Baseline Diastolic Blood Pressure Over Time
Timepoint [21] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [22] 0 0
Change from Baseline Electrocardiogram PR Interval Over Time
Timepoint [22] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [23] 0 0
Change from Baseline Electrocardiogram QRS Interval Over Time
Timepoint [23] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [24] 0 0
Change from Baseline Electrocardiogram Uncorrected QT Interval Over Time
Timepoint [24] 0 0
Baseline, Days 1, 2, 7, 22, and 63
Secondary outcome [25] 0 0
Number of Participants with Abnormal Clinical Laboratory Test Results as a Shift from Baseline to the Maximum Post-Baseline Severity Grade
Timepoint [25] 0 0
From Baseline until Day 63
Secondary outcome [26] 0 0
Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale
Timepoint [26] 0 0
Day 1: pre-dose, during drug injection, after drug injection while removing the device or syringe, and 2 hours after drug injection
Secondary outcome [27] 0 0
Number of Participants with Skin Irritation and Sensitization Reactions at the Injection Site
Timepoint [27] 0 0
Day 1
Secondary outcome [28] 0 0
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Timepoint [28] 0 0
Day 1
Secondary outcome [29] 0 0
Number of Healthcare Professionals by Their Ratings of Performance and Ease of Use of the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Timepoint [29] 0 0
Day 1

Eligibility
Key inclusion criteria
* Healthy male subjects age 18-45 years at time of signing Informed Consent Form
* Ability to comply with the study protocol
* Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, during the treatment period and for 7 months after the dose of PH FDC SC
* A body mass index (BMI) between 18 and 32 kilograms per metre squared (kg/m2), inclusive
* Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection on the thighs
* Baseline LVEF=55% measured by echocardiogram (ECHO)
* No history of hypersensitivity or confirmed, clinically significant and clinically relevant allergic reactions, either spontaneously or following any drug administration
* No history of any clinically significant and clinically relevant cardiac condition
* No history of previous anticancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
* No apparent family history of clinically significant and clinically relevant hypersensitivity, allergy, and severe cardiac diseases
* No contraindications from detailed medical and surgical history and physical examinations
* No previous enrollment in this study protocol and no concurrent enrollment in any other study protocol
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Positive urine test for drugs of abuse as per local standard (for alcohol abuse, positive breath test is also acceptable)
* Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 1 or 2, showing: History of exposure to HBV, HCV, or HIV; or Active viral hepatitis infection (HBV or HCV) or HIV infection
* Systolic blood pressure =140 millimetres of mercury (mmHg) or <90 mmHg, or diastolic blood pressure >90 mmHg or <50 mmHg
* Use of prohibited medications including non-prescription medications, nutraceuticals, nutritional supplements or any herbal remedies taken within 10 days or 5 times the elimination half-life (whichever is longer) prior to randomization into the study
* Concomitant subcutaneous, intravenous, or any parenteral drugs within 90 days prior to screening
* Participation in an investigational drug or device study within 90 days or five times the elimination half-life (whichever is longer) prior to screening
* Donation of blood over 500 millilitres (mL) within 3 months prior to enrollment
* Known severe hypersensitivity to plaster, medical adhesive tapes, or bandages
* Known allergy to murine proteins, hyaluronidase, bee, or vespid venom, or any other ingredient in the formulation of rHuPH20 (Hylenex® recombinant [hyaluronidase human injection]) or any other ingredients and excipients in the formulation of PH FDC SC
* Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, CBC, chemistry panel, and urinalysis)
* Clinically relevant electrocardiogram abnormalities at screening or Day -1
* History of any cardiac condition
* Lower extremity edema or pathology (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous lymph node dissection etc.) that could interfere with any protocol-specified outcome assessment
* Any history of clinically significant and clinically relevant allergies, oncologic, psychiatric, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease
* Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study
* Any clinically relevant history of systemic disease (e.g., malignancy, diabetes mellitus, gastrointestinal, renal, hepatic, cardiovascular, rheumatological, or pulmonary disease)
* History of breast cancer or treatment for breast cancer
* Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose =10 mg/day methylprednisolone), excluding inhaled corticosteroids
* Receipt of intravenous antibiotics for infection within 7 days prior to enrollment into the study

Study design
Purpose of the study
Other
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
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2023
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd; Nucleus Network Brisbane Clinic - Herston
Recruitment hospital [2] 0 0
CMAX Pty Ltd - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05275010