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.