A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00882674
First received: April 15, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Breast Cancer
Drug: RG1507
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percent reduction in IGF-1R expression [ Time Frame: From initial diagnosis to tumor excision ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue [ Time Frame: Days 1, 8 and 31 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients

  Eligibility

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

Inclusion Criteria:

  • female patients, >=18 years of age;
  • invasive, and operable, breast cancer;
  • ECOG Performance Status of 0 or 1.

Exclusion Criteria:

  • evidence of metastatic disease;
  • inflammatory breast cancer;
  • prior hormonal or systemic therapy for breast cancer;
  • prior treatment with an agent targetting the IGF-1R pathway;
  • patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882674

Locations
United Kingdom
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00882674     History of Changes
Other Study ID Numbers: NP22002, 2008-004128-22
Study First Received: April 15, 2009
Last Updated: April 7, 2014
Health Authority: Scotland: Scottish Executive Health Department

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014