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

Study 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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedVeliparib (ABT-888) and Placebo

The study team can explain what participation involves.

Who it may be forBreast Cancer · Ovarian Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 20, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Other
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Interventions being studied: Drug: Veliparib (ABT-888); Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Site Reference ID/Investigator# 116015Scottsdale, Arizona
Site Reference ID/Investigator# 116016San Antonio, Texas
Site Reference ID/Investigator# 117320Groningn
Site Reference ID/Investigator# 117336Maastricht
Site Reference ID/Investigator# 117517Madrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2017. Always confirm current availability with the study team.

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