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.