Cyclophosphamide Drug Interaction Study In Cancer Patients

Nausea and Vomiting, Chemotherapy-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00334646
• Other study ID #: NKV103444
• Status: Terminated
• Phase: Phase 1
• First received: June 6, 2006
• Last updated: November 13, 2017
• Start date: August 10, 2005
• Est. completion date: October 14, 2009

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 14, 2009
• Est. primary completion date: October 14, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Chemotherapy-Induced
• Vomiting

Intervention

Drug:
• Oral GW679769
150mg oral, once daily on days 1-3
• IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Christchurch
Sweden	GSK Investigational Site	Lund
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  New Zealand,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		throughout the study
Secondary	Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir		throughout the study

External Links

•   Results for study NKV103444 can be found on the GSK Clinical Study Register.