A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Veliparib

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 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.