This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.
This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the brain.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Oral Capsules
15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Site Reference ID/Investigator# 8334
Atlanta, Georgia, United States
Site Reference ID/Investigator# 52462
Chicago, Illinois, United States
Site Reference ID/Investigator# 24483
Kansas City, Kansas, United States
Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy
Time frame: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.
Safety Assessment Physical and Neurological Exam
Time frame: be performed at all study visits, final and follow-up visit
Safety Assessment Mini-Mental State Examination
Time frame: be performed at all study visits, final and follow-up visit
Safety Assessment Laboratory testing
Chemistry and Hematology labs will be collected
Time frame: be performed at all study visits, final and follow-up visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 7180
Baltimore, Maryland, United States
Site Reference ID/Investigator# 19021
Detroit, Michigan, United States
Site Reference ID/Investigator# 6344
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 6653
Madison, Wisconsin, United States
Site Reference ID/Investigator# 18542
Toronto, Canada
Site Reference ID/Investigator# 46322
Ponce, Puerto Rico