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

Phase 1

Completed

• Conditions: Colon Cancer; Gastric Cancer; Lung Cancer; Breast Cancer; Ovarian Cancer; Solid Tumors
• Interventions: Drug: Placebo; Drug: Veliparib (ABT-888)

• Registration Number: NCT02009631
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence Group C	Placebo	Placebo
Sequence Group A	Veliparib (ABT-888)	200 mg Veliparib
Sequence Group B	Veliparib (ABT-888)	400 mg Veliparib

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.	Blood pressure, heart rate and temperature.
Clinical Laboratory Tests	Up to 30 days after last dose of study drug.	Hematology, chemistry, urinalysis
Tumor Assessment	Screening	A computerized tomography scan will be done at screening to document tumor size.

Trial Locations

Locations (5)

Site Reference ID/Investigator# 117320; 🇳🇱 Groningn, Netherlands

Site Reference ID/Investigator# 116015; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 117336; 🇳🇱 Maastricht, Netherlands

Site Reference ID/Investigator# 116016; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 117517; 🇪🇸 Madrid, Spain