A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors
- Patients must have histologically or cytologically confirmed malignant solid tumor.
- Patients who are amenable to standard combination chemotherapy of carboplatin and
- 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
- 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
- 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.