Summary
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
Key Facts
Lead Sponsor
Enrollment
Start Date
Completion Date
Study Type
Official Title
Interventions
Conditions
Eligibility
Age Range
Sex
Inclusion Criteria: * Histologically or cytologically confirmed malignant solid tumor, and any of the following: \* Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; \* Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; \* Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy of greater than 12 weeks. * Adequate organ and marrow function· Measurable or non-measurable disease. Exclusion Criteria: * Major surgery and/or radiation within (\<) 4 weeks prior to study enrollment. * Chemotherapy or hormone therapy within (\<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks. * Any investigational agents within (\<) 4 weeks prior to study enrollment. * Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment. * Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.