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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


Phase 1
21 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer, Carcinoma, Renal Cell

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

throughout the study

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

VEG10007

NCT ID:

NCT00401583

Start Date:

July 2006

Completion Date:

February 2008

Related Keywords:

  • Solid Tumor Cancer
  • Carcinoma, Renal Cell
  • GW786034 (pazopanib) cytochrome P450 interaction
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

GSK Investigational SiteHooksett, New Hampshire  03106