Solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : veliparib (ABT-888)
INN of investigational material : veliparib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Inve
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety NCI-CTCAE V4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| PK analysis and preliminary efficacy of anti-tumor activity RECIST V1.1 | — |
Outcome results
None listed