Roche trials database

Trial information

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

Status:

Completed

Protocol number:

NP22002

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

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. Target sample size is 8.

Study phase:

I

Study type:

Interventional; Basic Science; Non-randomized; Open Label; Uncontrolled; Single group; Pharmacodynamics study

Conditions:

• Breast Cancer

Primary outcome:

1. Percent reduction in IGF-1R expression Time frame: From initial diagnosis to tumor excision

Key secondary outcomes:

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

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.

Gender:

Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

July, 2009

Trial registration date:

07.10.2008

Date last updated:

10.06.2013

This trial was conducted at the following locations:

United Kingdom

• EDINBURGH

Link to trial result