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

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ClinicalTrials.gov Identifier: NCT00401583
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: GW786034 (pazopanib) Drug: Probe drugs Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 28, 2006
Actual Primary Completion Date : February 20, 2008
Actual Study Completion Date : February 20, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pazopanib receivers
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)
Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
Drug: Probe drugs
probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).



Primary Outcome Measures :
  1. To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes. [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  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. [ Time Frame: throughout the study ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401583


Locations
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00401583     History of Changes
Other Study ID Numbers: VEG10007
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
GW786034 (pazopanib) cytochrome P450 interaction

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases