A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 11/22/2017 |
Start Date: | November 2013 |
End Date: | December 2014 |
A Randomized, Placebo-Controlled Crossover Study to Evaluate the Effect of Veliparib (ABT-888) on Cardiac Repolarization in Subjects With Relapsed or Refractory Solid Tumors
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.
repolarization in patients with solid tumors who's cancer has recurred or is no longer
responding to current treatment.
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.
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