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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.


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

AUC0-inf of trastuzumab

Outcome Time Frame:

At intervals throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

New Zealand: Institutional Review Board

Study ID:

BP22023

NCT ID:

NCT00800436

Start Date:

December 2008

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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