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

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ClinicalTrials.gov Identifier: NCT00882674
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: RG1507 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1 Drug: RG1507
16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients




Primary Outcome Measures :
  1. Percent reduction in IGF-1R expression [ Time Frame: From initial diagnosis to tumor excision ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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

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