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

Primary Purpose

Carcinoma, Renal Cell

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GW786034 (pazopanib)
Probe drugs
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring GW786034 (pazopanib) cytochrome P450 interaction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pazopanib receivers

Arm 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

Outcomes

Primary Outcome Measures

To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.

Secondary Outcome Measures

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.

Full Information

First Posted
November 17, 2006
Last Updated
November 8, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00401583
Brief Title
A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 28, 2006 (Actual)
Primary Completion Date
February 20, 2008 (Actual)
Study Completion Date
February 20, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
GW786034 (pazopanib) cytochrome P450 interaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pazopanib receivers
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
GW786034 (pazopanib)
Intervention Description
Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Probe drugs
Intervention Description
probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).
Primary Outcome Measure Information:
Title
To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
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.
Time Frame
throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
20881954
Citation
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.
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A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes

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