Cyclophosphamide Drug Interaction Study In Cancer Patients

Phase 1

Terminated

• Conditions: Nausea and Vomiting, Chemotherapy-Induced
• Interventions: Drug: Oral GW679769; Drug: IV Cyclophosphamide 500-700mg/m2

• Registration Number: NCT00334646
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-10
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-08
• Primary Completion: 2009-10-14
• Study Completion: 2009-10-14
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm B	Oral GW679769	cyclophosphamide + dexamethasone + ondansetron + GW679769
Arm A	IV Cyclophosphamide 500-700mg/m2	cyclophosphamide + dexamethasone + ondansetron

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Lund, Sweden