A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
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
2 other identifiers
interventional
45
3 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Nov 2013
Shorter than P25 for phase_1 breast-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 20, 2017
December 1, 2014
1.1 years
December 9, 2013
November 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
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 Outcomes (7)
Pharmacokinetic sampling maximum observed plasma concentration (Cmax)
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)
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)
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
Up to 30 days after last dose of study drug.
Vital Signs
Up to 30 days after last dose of study drug.
- +2 more secondary outcomes
Study Arms (3)
Sequence Group A
EXPERIMENTAL200 mg Veliparib
Sequence Group B
EXPERIMENTAL400 mg Veliparib
Sequence Group C
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (5)
Site Reference ID/Investigator# 116015
Scottsdale, Arizona, 85258, United States
Site Reference ID/Investigator# 116016
San Antonio, Texas, 78229, United States
Site Reference ID/Investigator# 117320
Groningn, 9713 GZ, Netherlands
Site Reference ID/Investigator# 117336
Maastricht, 6229 HX, Netherlands
Site Reference ID/Investigator# 117517
Madrid, 28050, Spain
Related Publications (1)
Munasinghe W, Stodtmann S, Tolcher A, Calvo E, Gordon M, Jalving M, de Vos-Geelen J, Medina D, Bergau D, Nuthalapati S, Hoffman D, Shepherd S, Xiong H. Effect of veliparib (ABT-888) on cardiac repolarization in patients with advanced solid tumors: a randomized, placebo-controlled crossover study. Cancer Chemother Pharmacol. 2016 Nov;78(5):1003-1011. doi: 10.1007/s00280-016-3156-x. Epub 2016 Oct 5.
PMID: 27709282RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stacie Shepherd, PhD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 20, 2017
Record last verified: 2014-12