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

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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.


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.
We found this trial at
3
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Scottsdale, AZ
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Groningn,
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San Antonio, TX
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