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

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

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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

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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Veliparib (ABT-888)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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