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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02009631

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Ovarian Cancer Colon Cancer Lung Cancer Gastric Cancer Solid Tumors	Drug: Veliparib (ABT-888) Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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 Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 116015	Scottsdale	Arizona	United States	85258
2	Site Reference ID/Investigator# 116016	San Antonio	Texas	United States	78229
3	Site Reference ID/Investigator# 117320	Groningn		Netherlands	9713 GZ
4	Site Reference ID/Investigator# 117336	Maastricht		Netherlands	6229 HX
5	Site Reference ID/Investigator# 117517	Madrid		Spain	28050