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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401583
• Other study ID #: VEG10007
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2006
• Last updated: November 8, 2017
• Start date: July 28, 2006
• Est. completion date: February 20, 2008

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 20, 2008
• Est. primary completion date: February 20, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• GW786034 (pazopanib)
Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
• Probe drugs
probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).

Locations

Country	Name	City	State
Singapore	GSK Investigational Site	Singapore
United States	GSK Investigational Site	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Singapore, 

References & Publications (1)

Goh BC, Reddy NJ, Dandamudi UB, Laubscher KH, Peckham T, Hodge JP, Suttle AB, Arumugham T, Xu Y, Xu CF, Lager J, Dar MM, Lewis LD. An evaluation of the drug interaction potential of pazopanib, an oral vascular endothelial growth factor receptor tyrosine kinase inhibitor, using a modified Cooperstown 5+1 cocktail in patients with advanced solid tumors. Clin Pharmacol Ther. 2010 Nov;88(5):652-9. doi: 10.1038/clpt.2010.158. Epub 2010 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.		throughout the study
Secondary	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

External Links

•   Results for study VEG10007 can be found on the GSK Clinical Study Register.