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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Gastric Cancer; Colon Cancer; Lung Cancer; Solid Tumors; Ovarian Cancer

Treatments: Drug: Veliparib (ABT-888); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02009631

2013-002028-18 (EudraCT Number)

M12-020

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Sequence Group A

Experimental group

Description:

200 mg Veliparib

Treatment:

Drug: Veliparib (ABT-888)

Sequence Group B

Experimental group

Description:

400 mg Veliparib

Treatment:

Drug: Veliparib (ABT-888)

Sequence Group C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo