Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Moxifloxacin

Norgestimate, ethinyl estradiol drug combination

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Norgestimate

Anti-Bacterial Agents

Enzyme Inhibitors

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptives, Oral

Contraceptives, Oral, Combined

Contraceptive Agents, Female

Subjects will receive pazopanib during study

Pazopanib

Placebo for pazopanib

Placebo for moxifloxacin

GSK Clinical Trials

This is a Phase I, randomized, double-blind, placebo-controlled, study to estimate the effects of daily oral dosing of 800 mg pazopanib on electrocardiographic parameters (QTc interval duration) as compared with placebo in subjects with solid tumors. Moxifloxacin, will serve as a positive control.

This is a Phase I, randomized, double-blind, placebo-controlled, parallel group study designed to estimate the effects of repeated, once daily oral dosing of pazopanib on electrocardiographic parameters with a particular focus on its effect on cardiac repolarization (QTc interval duration) as compared with placebo in subjects with solid tumors. Moxifloxacin, a drug known to cause mild QTc interval prolongation, is included as a positive control to validate the ability of the study to detect a small prolongation in the QTc interval. Digital 12-lead electrocardiograms (ECGs) will be extracted from continuous ECG recordings obtained via a Holter monitor. The effects of pazopanib and moxifloxacin on cardiac repolarization will be compared with placebo.

This study will also assess the pharmacokinetic-pharmacodynamic relationship between plasma concentrations of pazopanib and its metabolites and their effects, if any, on cardiac repolarization, specifically on the QT interval.

VEG111485: A QTc Study of Pazopanib

A Randomized, Blinded Placebo-Controlled Study to Evaluate the Effect of Repeat Oral Doses of Pazopanib (GW786034) on the Electrocardiogram (ECG) With Focus on Cardiac Repolarization (QTc Duration) in Subjects With Solid Tumors

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
VEG111485: A QTc Study of Pazopanib	NCT00861029	Carcinoma, Rena...	Pazopanib Placebo for paz... Moxifloxacin Placebo for mox...	18 Years -	GlaxoSmithKline
VEG111485: A QTc Study of Pazopanib	NCT00861029	Carcinoma, Rena...	Pazopanib Placebo for paz... Moxifloxacin Placebo for mox...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for gw786034, pazopanib, moxifloxacin, ecg intervals and morphology, qtc, holter monitor, pharmacokinetics, safety, cancer