Cyclophosphamide Drug Interaction Study In Cancer Patients

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00334646

Enrollment

Registered

2006-06-08

Start date

2005-08-10

Completion date

2009-10-14

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Keywords

cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting

Brief summary

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

Interventions

DRUGOral GW679769

150mg oral, once daily on days 1-3

DRUGIV Cyclophosphamide 500-700mg/m2

IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir	throughout the study

Countries

New Zealand, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026