A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
RG1507
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percent reduction in IGF-1R expression
Secondary Outcome Measures
Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
Adverse events, laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882674
Brief Title
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RG1507
Intervention Description
16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients
Primary Outcome Measure Information:
Title
Percent reduction in IGF-1R expression
Time Frame
From initial diagnosis to tumor excision
Secondary Outcome Measure Information:
Title
Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
Time Frame
Days 1, 8 and 31
Title
Adverse events, laboratory parameters
Time Frame
Throughout study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
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