Back to resultsA Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
Primary Purpose
Breast Cancer, Ovarian Cancer, Colon Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Veliparib (ABT-888)
Placebo
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Solid Tumors, Ovarian Cancer, Colon Cancer, Lung Cancer, Breast Cancer, Gastric Cancer
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 116015
- Site Reference ID/Investigator# 116016
- Site Reference ID/Investigator# 117320
- Site Reference ID/Investigator# 117336
- Site Reference ID/Investigator# 117517
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Sequence Group A
Sequence Group B
Sequence Group C
Arm Description
200 mg Veliparib
400 mg Veliparib
Placebo
Outcomes
Primary Outcome Measures
To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF)
Secondary Outcome Measures
Pharmacokinetic sampling maximum observed plasma concentration (Cmax)
Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax)
Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24)
The number of subjects with adverse events
Vital Signs
Blood pressure, heart rate and temperature.
Clinical Laboratory Tests
Hematology, chemistry, urinalysis
Tumor Assessment
A computerized tomography scan will be done at screening to document tumor size.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02009631
Brief Title
A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Cancer, Colon Cancer, Lung Cancer, Gastric Cancer, Solid Tumors
Keywords
Solid Tumors, Ovarian Cancer, Colon Cancer, Lung Cancer, Breast Cancer, Gastric Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence Group A
Arm Type
Experimental
Arm Description
200 mg Veliparib
Arm Title
Sequence Group B
Arm Type
Experimental
Arm Description
400 mg Veliparib
Arm Title
Sequence Group C
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Veliparib (ABT-888)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
The number of subjects with adverse events
Time Frame
Up to 30 days after last dose of study drug.
Title
Vital Signs
Description
Blood pressure, heart rate and temperature.
Time Frame
Up to 30 days after last dose of study drug.
Title
Clinical Laboratory Tests
Description
Hematology, chemistry, urinalysis
Time Frame
Up to 30 days after last dose of study drug.
Title
Tumor Assessment
Description
A computerized tomography scan will be done at screening to document tumor size.
Time Frame
Screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacie Shepherd, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 116015
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Site Reference ID/Investigator# 116016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 117320
City
Groningn
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 117336
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 117517
City
Madrid
ZIP/Postal Code
28050
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27709282
Citation
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.
Results Reference
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A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
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