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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Information provided by (Responsible Party): | Reshma Jagsi, MD, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01477489 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Veliparib Radiation: Standard radiation treatment |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Reshma Jagsi, MD, Associate Professor of Radiation Oncology, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01477489 History of Changes |
| Other Study ID Numbers: | UMCC 2011.087 |
| Study First Received: | November 18, 2011 |
| Last Updated: | November 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |