A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors

A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed malignant solid tumor.
• Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.
• Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Patients must have normal organ and marrow function

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2.
• Known history of allergic reactions to carboplatin or cremophor-paclitaxel.
• Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of seizure disorder.
• Hepatitis B surface antigen (HBsAg) positive, Hepatitis C virus (HCV) antibody positive or Human immunodeficiency virus (HIV)-positive patients.