Clinical Trial Protocol Registry
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
- Protocol number:
- Hoffmann-La Roche
- Company division:
- 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:
- Study type:
- Interventional; Basic Science; Non-randomized; Open Label; Uncontrolled; Single group; Pharmacodynamics study
- Breast Cancer
- Primary outcome:
- Percent reduction in IGF-1R expression Time frame: From initial diagnosis to tumor excision
- Key secondary outcomes:
- Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue Time frame: Days 1, 8 and 31
- 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.
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- July, 2009
- Trial registration date:
- Date last updated:
For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.
- Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.
Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.
For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)
- 1-888-662-6728 Monday to Friday (6am to 3pm PST)