A Phase I Study of Veliparib (ABT-888) in Combination With Low-dose Fractionated Whole Abdominal Radiation Therapy (LDFWAR) in Patients With Advanced Solid Malignancies With Peritoneal Carcinomatosis
I. Determine the maximum tolerable dose of veliparib in combination with low-dose
fractionated whole abdominal radiation therapy (LDFWAR) in patients with peritoneal
carcinomatosis from advanced solid malignancies.
II. Determine the safety and toxicity of the combination of veliparib in conjunction with
LDFWAR in patients with peritoneal carcinomatosis from advanced solid malignancies.
I. Assess clinical activity of veliparib plus LDFWAR in patients with peritoneal
carcinomatosis from advanced solid malignancies as assessed by response rate by Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
II. Evaluate if microsatellite instability or baseline levels of various deoxyribonucleic
acid (DNA) repair proteins (excision repair cross-complementing 1 [ERCC1], x-ray repair
complementing defective repair in Chinese hamster cells 1 [XRCC1], breast cancer 1, early
onset (BRCA1), breast cancer 2, early onset [BRCA2], poly [ADP-ribosyl]ation [PAR])
correlate with clinical activity of this regimen.
III. Evaluate changes in quality of life for patients treated with this regimen by serial
measurements using the Quality of Life Questionnaire Core-30 (QLQC-30) standardized
OUTLINE: This is a dose escalation study of veliparib.
Patients will take veliparib orally (PO) twice daily (BID) on days 1-21. LDFWAR will be
administered in two fractions every Monday and Friday for weeks 1-3 of each course. Courses
will be 28 days long. Three courses only of LDFWAR will be administered.
After completion of study treatment, patients are followed up every 2 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of veliparib in combination with LDFWAR defined as the highest dose at which 0 or 1 dose-limiting toxicities are observed in six patients
Reported with exact binomial proportions and 95% confidence intervals.
Johns Hopkins University
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|