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

November 16, 2017 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningn, Netherlands, 9713 GZ
        • Site Reference ID/Investigator# 117320
      • Maastricht, Netherlands, 6229 HX
        • Site Reference ID/Investigator# 117336
  • Spain
      • Madrid, Spain, 28050
        • Site Reference ID/Investigator# 117517
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Site Reference ID/Investigator# 116015
    • Texas
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 116016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence Group A
200 mg Veliparib
Drug: Veliparib (ABT-888)
Experimental: Sequence Group B
400 mg Veliparib
Drug: Veliparib (ABT-888)
Placebo Comparator: Sequence Group C
Placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
Time Frame: Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3.
Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic sampling maximum observed plasma concentration (Cmax)
Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax)
Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24)
Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3.
The number of subjects with adverse events
Time Frame: Up to 30 days after last dose of study drug.
Up to 30 days after last dose of study drug.
Vital Signs
Time Frame: Up to 30 days after last dose of study drug.
Blood pressure, heart rate and temperature.
Up to 30 days after last dose of study drug.
Clinical Laboratory Tests
Time Frame: Up to 30 days after last dose of study drug.
Hematology, chemistry, urinalysis
Up to 30 days after last dose of study drug.
Tumor Assessment
Time Frame: Screening
A computerized tomography scan will be done at screening to document tumor size.
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Stacie Shepherd, PhD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-020
  • 2013-002028-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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