This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
45
Site Reference ID/Investigator# 116015
Scottsdale, Arizona, United States
Site Reference ID/Investigator# 116016
San Antonio, Texas, United States
Site Reference ID/Investigator# 117320
Groningn, Netherlands
Site Reference ID/Investigator# 117336
Maastricht, Netherlands
To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
Time frame: Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3.
Pharmacokinetic sampling maximum observed plasma concentration (Cmax)
Time frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax)
Time frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24)
Time frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
The number of subjects with adverse events
Time frame: Up to 30 days after last dose of study drug.
Vital Signs
Blood pressure, heart rate and temperature.
Time frame: Up to 30 days after last dose of study drug.
Clinical Laboratory Tests
Hematology, chemistry, urinalysis
Time frame: Up to 30 days after last dose of study drug.
Tumor Assessment
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Site Reference ID/Investigator# 117517
Madrid, Spain
A computerized tomography scan will be done at screening to document tumor size.
Time frame: Screening