A Phase 1 Study of veliparib (ABT-888) in Combination with Carboplatin/Paclitaxel in Japanese Subjects with solid tumors
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080221796
- Lead Sponsor
- AbbVie GK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 12
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>NCI-CTCAE V4.03
- Secondary Outcome Measures
Name Time Method PK analysis and preliminary efficacy of anti-tumor activity <br>RECIST V1.1