CompletedPhase 1NCT02009631

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

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

StatusCompleted
PhasePhase 1
U.S. locations5
SponsorAbbVie
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

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

04
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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