NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Solid tumors
Date of first enrollment	23/05/2012
Target sample size	12
Countries of recruitment
Study type	Interventional
Intervention(s)	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 Investigational material : Twice-daily doses (BID) of oral veliparib on Days 1-7 in each cycle. Generic name etc : carboplatin INN of investigational material : carboplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration on Day 3 of each cycle. Generic name etc : paclitaxel INN of investigational material : paclitaxel Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Intravenous administration on Day 3 of each cycle.

Outcome(s)

Primary Outcome	Safety NCI-CTCAE V4.03
Secondary Outcome	PK analysis and preliminary efficacy of anti-tumor activity RECIST V1.1

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.