MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PK-profile: concentration - sampling at 0.75, 1.5, 2, 3, 4, 5, 6, 8, 24, 48,
and 96 hours post dose, and 8, 14, 21, 28, 35, 42, 49, and 63 days post dose
(to demonstrate bioequivalence).
Safety and tolerability: general chemistry/haematology and urinalysis, cardiac
markers, echocardiography, ECG, observation and questions, vital signs.
Secondary outcome
PK-profile: concentration - sampling at 0.75, 1.5, 2, 3, 4, 5, 6, 8, 24, 48,
and 96 hours post dose, and 8, 14, 21, 28, 35, 42, 49, and 63 days post dose
(to evaluate pharmacokinetic parameters).
Background summary
Herceptin has been on the market for over a decade and has established a firm
position in the treatment of breast cancer and metastatic gastric cancer.
However, Herceptin is the only drug in its class. The purpose of this study is
to evaluate the safety profile and PK-parameters of FTMB, a biosimilar of
Herceptin/trastuzumab, expanding choice for prescribers, and ultimately
reducing costs.
Study objective
MAIN OBJECTIVES
Dose escalation study:
To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in
healthy volunteers at different dose levels up to 6 mg/kg.
Bioequivalence study:
Demonstrate bioequivalence between trastuzumab (Synthon BV, the Netherlands)
and Herceptin® (Hoffmann-La Roche, Switzerland) at a
dose level of 6 mg/kg.
SECONDARY OBJECTIVES
To assess the pharmacokinetic profile of trastuzumab.
To evaluate safety of trastuzumab.
Study design
Randomised placebo-controlled double blind dose escalation & parallel
laboratory blinded bioequivalence.
Intervention
FTMB, Herceptin or placebo (infusion).
Study burden and risks
Infusion-related reactions can occur, are usually mild, and easily managed. The
risk of trastuzumab-induced cardiomyopathy has been assessed as very low, and
will be closely monitored.
There is no direct benefit to subjects participating in this study as they are
healthy men, however they contribute to the development of a novel drug in its
class against breast cancer, a common disease associated with high mortality
and morbidity. Subjects will be financially compensated for their
participation.
Microweg 22
6503 GN Nijmegen
NL
Microweg 22
6503 GN Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Healthy males, 18-45 years of age
Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive;
Subject is available for the entire study period and will provide his written informed consent;
Physical examination without significant deviations;
Vital signs, Electro Cardiogram (ECG) and Echo Cardiogram (Echo) without significant deviations;
All laboratory screening results within the normal range or being assessed as non-significant by the attending physician.
Baseline LVEF > 55%.
Exclusion criteria
History and/or current presence of hypersensitivity or allergic reactions, spontaneous or following a drug administration;
History and/or current presence of cardiac conditions, or any abnormal echo cardiogram finding (e.g. regional wall motion abnormality or signs of hypertrophic cardiomyopathy);
History and/or current presence of significant gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease;
Clinically significant illness within four weeks before study start;
Any significant clinical abnormality, including a positive test for HBsAg, HCV, or HIV;
Serious mental disease;
Drug, alcohol, solvents or caffeine abuse;
Smoking more than 10 cigarettes (or 2 cigars or 2 pipes) per day;
Regular use of medication for at least three months;
Use of organ-toxic drugs within three months before study start, or use of drugs with a well-defined potential for toxicity to a major organ or system (for example chloramphenicol, which may cause bone marrow suppression);
Any systemic prescription treatment within 14 days before study start;
Any systemic over-the-counter (OTC) drug treatment within 7 days before study start;
Loss of blood outside the limits of Sanquin within 3 months prior to screening;
Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times a year;
Positive test for drugs of abuse at screening;
Any condition that in the opinion of the investigator could jeopardize the subject*s health and/or well-being.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002972-17-NL |
| CCMO | NL37452.056.11 |