MedDataX Logo

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

NCT ID: NCT02009631

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Ovarian Cancer Colon Cancer Lung Cancer Gastric Cancer Solid Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Solid Tumors Ovarian Cancer Colon Cancer Lung Cancer Breast Cancer Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence Group A

200 mg Veliparib

Group Type EXPERIMENTAL

Veliparib (ABT-888)

Intervention Type DRUG

Sequence Group B

400 mg Veliparib

Group Type EXPERIMENTAL

Veliparib (ABT-888)

Intervention Type DRUG

Sequence Group C

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Veliparib (ABT-888)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stacie Shepherd, PhD

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 116015

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 116016

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 117320

Groningn, , Netherlands

Site Status

Site Reference ID/Investigator# 117336

Maastricht, , Netherlands

Site Status

Site Reference ID/Investigator# 117517

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Netherlands Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27709282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-002028-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M12-020

Identifier Type: -

Identifier Source: org_study_id