A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes

A Multi-center, Open-Label, Multiple-probe Drug Interaction Study to Determine the Effects of GW786034 on the Metabolism of Cytochrome P450 Probe Drugs in Patients With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401583

Enrollment

Registered

2006-11-20

Start date

2006-07-28

Completion date

2008-02-20

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

GW786034 (pazopanib) cytochrome P450 interaction

Brief summary

This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034.

Interventions

DRUGGW786034 (pazopanib)

Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.

DRUGProbe drugs

probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed diagnosis of advanced solid tumors. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow, renal, lung, and liver function. * A female subject must not be pregnant and will agree not to become pregnant during the trial

Exclusion criteria

* Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days. * Poorly controlled hypertension. * Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities. * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months. * Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents). Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug. * History of brain metastases. * Has narrow-angle glaucoma which is a contraindication to midazolam use. * History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months. * A history of bleeding problems.

Design outcomes

Primary

Measure	Time frame
To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.	throughout the study

Secondary

Measure	Time frame
Safety of co-administration of 800 mg daily GW786034 and CYP450 probe drugs. To describe GW786034 steady-state pharmacokinetics on this once daily dosing regimen.	throughout the study

Countries

Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026