A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT01617928
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description veliparib (ABT-888) veliparib (ABT-888) - veliparib (ABT-888) paclitaxel - veliparib (ABT-888) carboplatin -
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose and recommended Phase two dose During the first cycle (21 days from first dose of veliparib)
- Secondary Outcome Measures
Name Time Method Safety assessment; Adverse event monitoring From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) Collect all adverse events at each visit
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel Six timepoints on Day 3 of first cycle (21 days) Safety assessment; Change from Baseline in Electrocardiogram (ECG) Day 8 of first cycle (21 days) Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) Eight timepoints on Day 1 of first cycle (21 days) Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel Eight timepoints on Day 3 of first cycle (21 days) Preliminary tumor response From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles. Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
Safety assessment; Physical exam including vital signs From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) Blood pressure, pulse and body temperature
Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin Eight timepoints on Day 3 of first cycle (21 days) Safety assessment; Clinical lab testings From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) Hematology, Chemistry and Urinalysis
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 68622
🇯🇵Tokyo, Japan