What is involved?
This is a dose-escalation, phase I study of veliparib followed by a phase II study.
Dose-escalation: Patients receive veliparib orally (PO) twice daily (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal or intensity-modulated radiotherapy once daily (QD) 5 days a week for 6-7 weeks.
Maintenance therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic studies (required in phase I, optional in phase II). Patients may also undergo peripheral blood mononuclear cells and urine sample collection for PARP activity, γ-H2AX levels, and other biomarker studies. Tumor tissue samples from biopsy may be also collected.
After completion of study treatment, patients are followed up periodically for up to 3 years.