The purpose of this study is to determine the maximum tolerated dose of veliparib that can be given while a patient is receiving radiation therapy.
Veliparib is an investigational drug known as a "PARP inhibitor." Because veliparib affects the way that cells repair damage, veliparib may be useful in combination with radiation treatment because it may help make radiation work better. Veliparib is an oral medication that will be taken twice daily during the 6 weeks a patient is receiving radiation therapy. The researchers will also be analyzing blood and tissue taken from the skin of patients. The skin biopsies will help determine which patients are more sensitive to treatment with radiation combined with the study drug. While the blood sample will allow researchers to see if the way a person's body processes drugs affects how the patient responds to treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.
Limited to 60 Gy.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke
Durham, North Carolina, United States
To determine the maximum tolerated dose of veliparib that can be administered concurrently with standard doses of radiotherapy to the chest wall and regional nodes.
Time frame: 12-24 months
To describe the nature of toxicity that develops when PARP inhibitors are administered concurrently with chest wall radiotherapy.
Time frame: 12-24 months
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MD Anderson Cancer Center
Houston, Texas, United States