NCT00401583

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2006

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2008

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.6 years

First QC Date

November 17, 2006

Last Update Submit

November 8, 2017

Conditions

Carcinoma, Renal Cell

Keywords

GW786034 (pazopanib) cytochrome P450 interaction

Outcome Measures

Primary Outcomes (1)

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

    throughout the study

Secondary Outcomes (1)

  • 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

Study Arms (1)

Pazopanib receivers

EXPERIMENTAL

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

Drug: GW786034 (pazopanib)Drug: Probe drugs

Interventions

GW786034 (pazopanib)DRUG

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

Pazopanib receivers
Probe drugsDRUG

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

Pazopanib receivers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

GSK Investigational Site

Singapore, 119074, Singapore

Location

Related 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.

    PMID: 20881954BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

July 28, 2006

Primary Completion

February 20, 2008

Study Completion

February 20, 2008

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

SG(1)US(1)