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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882674
First Posted: April 16, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue [ Time Frame: Days 1, 8 and 31 ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00882674     History of Changes
Other Study ID Numbers: NP22002
2008-004128-22
First Submitted: April 15, 2009
First Posted: April 16, 2009
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases