Overview

Cyclophosphamide Drug Interaction Study In Cancer Patients

Status:
Terminated
Trial end date:
2009-10-14
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Casopitant
Cyclophosphamide
Criteria
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.