A Phase II Study of Whole Brain Radiation with and without Veliparib in Patients with Brain Metastases from Non-Small Cell Lung Cancer

Protocol
13-051
Full Title
A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects with Brain Metastases from Non-Small Cell Lung Cancer
Phase
II
Purpose

When non-small cell lung cancer (NSCLC) metastasizes to other parts of the body, it may spread to the brain. Whole brain radiation therapy is one way to treat these brain metastases, but they often continue to grow.

Veliparib (also called ABT-888) is an investigational drug being assessed for treating several types of cancer. It kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer treatments. Veliparib may make whole brain radiation treatment work more effectively against brain metastases from NSCLC.

The purpose of this study is to evaluate the safety and effectiveness of whole brain radiation therapy with veliparib and with a placebo in patients with brain metastases from NSCLC. Patients will be randomly assigned to one of three groups: whole brain radiation plus low-dose veliparib, whole brain radiation plus high-dose veliparib, or whole brain radiation plus a placebo. Veliparib is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have brain metastases from NSCLC that were diagnosed within 28 days of entering the study.
  • Patients should be eligible for treatment with whole brain radiation therapy.
  • Patients may not have previously received surgery or radiation therapy to treat their brain metastases.
  • At least a week must have passed since completion of prior anticancer therapies and entry into the study.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Kathryn Beal at 212-639-5159.

Disease(s)
Brain Tumors, Metastatic
Lung Cancer, Non-Small Cell
Locations
Related Diseases