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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882674
• Other study ID #: NP22002
• Secondary ID: 2008-004128-22
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2009
• Last updated: November 1, 2016
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in IGF-1R expression		From initial diagnosis to tumor excision	No
Secondary	Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue		Days 1, 8 and 31	No
Secondary	Adverse events, laboratory parameters		Throughout study	No