cancer solid tumors
Conditions
Interventions
Subjects who participate in the clinical trial will pay extra visits to the
hospital. The study is divided in three periods. Each period lasts 3 to 7 days
During these visits blood will be drawn for
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. - Subjects with brain metastases must have clinically controlled neurologic sysptoms. - Subject is able to swallow and retain oral medications and does not have uncontrolled emesis. - Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges. - Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: - Subject has a screening or baseline (pre-dose on Day 1 of Period 1 at approximately 8 - 10 AM) corrected QT interval (QTc) interval by Fridericia's correction (QTcF) > 470 ms. - Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxine (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia. - Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult. - Subject has a history of cardiac conduction abnormalities including: • PR interval > 220 ms or 136 ms; • bradycardia as defined by sinus rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the effect of veliparib on QTcF. Evaluation of this point will be done once 36 subjects have completed all 3 dosing periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed