Status:
TERMINATED
Cyclophosphamide Drug Interaction Study In Cancer Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nausea and Vomiting, Chemotherapy-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00334646
Start Date
August 10 2005
End Date
October 14 2009
Last Update
November 17 2017
Active Locations (5)
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1
GSK Investigational Site
Newark, Delaware, United States, 19713
2
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
3
GSK Investigational Site
The Bronx, New York, United States, 10461
4
GSK Investigational Site
Christchurch, New Zealand, 8011