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

Completed · Phase 1 · Has a placebo group

Conditions studied: Breast Cancer, Ovarian Cancer, Colon Cancer, Lung Cancer, Gastric Cancer, Solid Tumors

In brief

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.

Key facts

Study ID

NCT02009631

Run by

AbbVie

People needed

45

Starts

2013-11-01

Expected to finish

2014-12-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 116015 — Scottsdale, Arizona, United States
• Site Reference ID/Investigator# 116016 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 117320 — Groningn, Netherlands
• Site Reference ID/Investigator# 117336 — Maastricht, Netherlands
• Site Reference ID/Investigator# 117517 — Madrid, Spain

Full record on ClinicalTrials.gov

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