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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Probe drugs; Drug: GW786034 (pazopanib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401583

VEG10007

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Pazopanib receivers

Experimental group

Description:

During Days 1 and 2 subjects will be dosed with only probe drugs, and with no drugs on Days 3-5. During Days 6 to the end of the study, subjects will receive 800 mg daily pazopanib, and on Days 23-24 subjects will receive probe drugs in addition to pazopanib

Treatment:

Drug: GW786034 (pazopanib)

Drug: Probe drugs