Trial information
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Status: Recruiting
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
70
.
Study phase: I
Study type: Interventional; Basic Science; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacodynamics study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: R1507
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
Trial registration date: 04/15/2009
Date last updated: 8/4/2009
Link to trial result
This trial is being conducted at the following locations:
United Kingdom
