NCT01477489

Veliparib With Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

A Phase 1 Study of Veliparib Administered Concurrently With Chest Wall and Nodal Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Veliparib	Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.
RADIATION	Standard radiation treatment	Limited to 60 Gy.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-10-01
• Completion: 2017-10-01
• First posted: 2011-11-22
• Last updated: 2017-12-15

Locations

5 sites across 1 country: United States