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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800436
First received: December 1, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 2 part study will select the subcutaneous(sc) dose of Herceptin which resul ts in comparable exposure to intravenous(iv) Herceptin in healthy male volunteer s and in HER2 positive female patients, and will assess the safety and tolerabil ity 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--6 mg/kg sc in healthy male volunteers; Cohort 4 --10mg/kg sc in healthy male volun teers. 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 t he target sample size is <100 individuals.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AUC0-inf of trastuzumab [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, laboratory parameters, PK parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
6mg/kg iv (healthy males)
Experimental: 2 Drug: trastuzumab [Herceptin]
6mg/kg iv (female patients)
Experimental: 3 Drug: trastuzumab [Herceptin]
6mg/kg sc (healthy males)
Experimental: 4 Drug: trastuzumab [Herceptin]
10mg/kg sc (healthy males)
Experimental: 5 Drug: trastuzumab [Herceptin]
<12mg/kg sc (female patients)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800436

Locations
Australia
East Bentleigh, Australia, VIC 3165
New Zealand
Christchurch, New Zealand, 8011
Grafton, New Zealand, 1150
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800436     History of Changes
Other Study ID Numbers: BP22023
Study First Received: December 1, 2008
Last Updated: October 6, 2014
Health Authority: New Zealand: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014