Trial Information
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
NKV103444
NCT ID:
NCT00334646
Start Date:
August 2005
Completion Date:
September 2009
Related Keywords:
- Nausea and Vomiting, Chemotherapy-Induced
- Cancer
- cyclophosphamide
- CINV
- Chemotherapy induced nausea and vomiting
- Nausea
- Vomiting
Name | Location |
|---|
| GSK Investigational Site |
New York, New York 10021 |
| GSK Investigational Site |
Newark, Delaware 19713 |
