A Dose Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and HER2 Positive Female Patients

Breast Cancer Clinical Trial

Official title:

An Open-label, Two-part, Multi-center Dose-finding Study in Healthy Male Volunteers and Women Who Have Previously Received Herceptin to Compare Exposure of Single Dose Trastuzumab After Intravenous (IV) and Subcutaneous (SC) Administration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800436
• Other study ID #: BP22023
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2008
• Last updated: April 2, 2016
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This 2 part study will select the subcutaneous(sc) dose of Herceptin which results in comparable exposure to intravenous(iv) Herceptin in healthy male volunteers and in HER2 positive female patients, and will assess the safety and tolerability of the 2 formulations. In the first part of the study, 4 cohorts of subjects will be treated with a single dose of Herceptin as follows: Cohort 1--6mg/kg iv in healthy male volunteers; Cohort 2--6mg/kg iv in female patients; Cohort 3--6mg/kg sc in healthy male volunteers; Cohort 4 --10mg/kg sc in healthy male volunteers. In part 2 of the study, the chosen sc dose (<12mg/kg)will be confirmed in female patients. Patients will receive a maximum of 2 doses of Herceptin, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy volunteers (Part 1 only)

• males, 18-45 years of age;

• no history of hypersensitivity or allergic reaction, spontaneous or following drug administration;

• no history of cardiac conditions. Patients (Part 1 and 2)

• females, >=18 years of age;

• ECOG performance status of 0;

• previous non-metastatic operable primary invasive HER2 positive breast cancer;

• baseline LVEF >55%.

Exclusion Criteria:

Healthy volunteers (Part 1 only)

• clinically significant abnormalities in laboratory test results or ECGs;

• LVEF<60%;

• history of significant allergies, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease.

patients (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 herception in previous 5 months;

• serious cardiac illness.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• trastuzumab [Herceptin]
6mg/kg iv (healthy males)
• trastuzumab [Herceptin]
6mg/kg iv (female patients)
• trastuzumab [Herceptin]
6mg/kg sc (healthy males)
• trastuzumab [Herceptin]
10mg/kg sc (healthy males)
• trastuzumab [Herceptin]
<12mg/kg sc (female patients)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf of trastuzumab		At intervals throughout study	No
Secondary	Adverse events, laboratory parameters, PK parameters		Throughout study	No