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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009631
• Other study ID #: M12-020
• Secondary ID: 2013-002028-18
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2013
• Last updated: November 16, 2017
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Solid Tumors
• Stomach Neoplasms

Intervention

Drug:
• Veliparib (ABT-888)

• Placebo

Locations

Country	Name	City	State
Netherlands	Site Reference ID/Investigator# 117320	Groningn
Netherlands	Site Reference ID/Investigator# 117336	Maastricht
Spain	Site Reference ID/Investigator# 117517	Madrid
United States	Site Reference ID/Investigator# 116016	San Antonio	Texas
United States	Site Reference ID/Investigator# 116015	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Netherlands,  Spain, 

References & 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 rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	The number of subjects with adverse events		Up to 30 days after last dose of study drug.
Secondary	Vital Signs	Blood pressure, heart rate and temperature.	Up to 30 days after last dose of study drug.
Secondary	Clinical Laboratory Tests	Hematology, chemistry, urinalysis	Up to 30 days after last dose of study drug.
Secondary	Tumor Assessment	A computerized tomography scan will be done at screening to document tumor size.	Screening