Cyclophosphamide Drug Interaction Study In Cancer Patients

Phase 1TerminatedNCT00334646

GlaxoSmithKline25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Interventions

Oral GW679769DRUG

150mg oral, once daily on days 1-3

IV Cyclophosphamide 500-700mg/m2DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

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.

Time frame: throughout the study

Secondary Outcomes

Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir

Time frame: throughout the study

Data from ClinicalTrials.gov

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