Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Solid Tumors
Conditions
Keywords
Solid Tumors, Ovarian Cancer, Colon Cancer, Lung Cancer, Breast Cancer, Gastric Cancer
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 symptoms. * 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.
Exclusion criteria
* Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (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. * Subject has a significant history of cardiovascular disease. * Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy. * Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose. * Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax) | 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) | 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 | Up to 30 days after last dose of study drug. | — |
| Pharmacokinetic sampling maximum observed plasma concentration (Cmax) | 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. | — |
| Clinical Laboratory Tests | Up to 30 days after last dose of study drug. | Hematology, chemistry, urinalysis |
| Tumor Assessment | Screening | A computerized tomography scan will be done at screening to document tumor size. |
| Vital Signs | Up to 30 days after last dose of study drug. | Blood pressure, heart rate and temperature. |
Countries
Netherlands, Spain, United States
Outcome results
None listed