Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Institutes of Health Clinical Center (CC)
With
OBJECTIVES: Primary * Determine the dose-range at which ABT-888 inhibits poly (ADP-ribose) polymerase (PARP) in tumor samples and in peripheral blood mononuclear cells (PBMCs) in patients with refractory solid tumors or lymphoid malignancies. * Determine the pharmacokinetics of ABT-888. * Determine the time course of PARP inhibition in PBMCs by ABT-888. Secondary * Determine the safety of administering 1 dose of ABT-888 in these patients. OUTLINE: This is a dose-finding study. Patients receive oral ABT-888 once on day 1. Cohorts of 3 patients receive escalating doses of ABT-888 until significant tumor poly (ADP-ribose) polymerase (PARP) inhibition is observed in 3 of 3 patients at 2 dose levels. Significant PARP inhibition is defined as ≥ 0.69 reduction on the log scale in poly (ADP-ribose) level from baseline to 3-6 hours after ABT-888 administration (with 90% confidence that it is not due to chance variation). Patients undergo peripheral blood collection at baseline and periodically after ABT-888 administration for PARP inhibition, pharmacokinetic, and pharmacodynamic studies. Once significant PARP inhibition is observed in 1 of 3 patients, subsequently enrolled patients also undergo tumor biopsy\* at baseline and 3-6 hours or 21-27 hours after ABT-888 administration to determine PARP inhibition in tumor tissue. NOTE: \*Patients with chronic lymphocytic leukemia undergo peripheral blood collection instead of biopsy. After completion of ABT-888 administration, patients are followed for 7 days. PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
