Cyclophosphamide Drug Interaction Study In Cancer Patients

Stopped early · Phase 1

Conditions studied: Nausea and Vomiting, Chemotherapy-Induced

In brief

This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.

Key facts

Study ID

NCT00334646

Run by

GlaxoSmithKline

People needed

25

Starts

2005-08-10

Expected to finish

2009-10-14

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Christchurch, New Zealand
• GSK Investigational Site — Lund, Sweden

Full record on ClinicalTrials.gov

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