A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

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.

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.