A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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