An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients
- Histologically or cytologically confirmed diagnosis of cancer.
- Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose
of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
- Adequate hematologic, renal and hepatic function.
- Pregnant or lactating.
- CNS (central nervous system) metastases.
- Active systemic infection or any other poorly controlled medical condition.
- Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4
inducers within 48 days of study treatment.
Type of Study:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting.
Outcome Time Frame:
throughout the study
GSK Clinical Trials
United States: Food and Drug Administration
- Nausea and Vomiting, Chemotherapy-Induced
- Chemotherapy induced nausea and vomiting
|GSK Investigational Site||New York, New York 10021|
|GSK Investigational Site||Newark, Delaware 19713|