Cyclophosphamide Drug Interaction Study In Cancer Patients - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00334646

Purpose

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

Condition	Intervention	Phase
Cancer	Drug: Oral GW679769 Drug: IV Cyclophosphamide 500-700mg/m2	Phase I

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Cyclophosphamide GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamide Safety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting. [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Terminal t1/2, Vd, and Cl of cyclophosphamide Terminal t1/2 of 4-hydroxycyclophosphamide AUC ratio of 4-hydroxycyclophosphamide and cyclophosphamide ANC nadir [ Time Frame: throughout the study ]

Estimated Enrollment:	16
Study Start Date:	August 2005
Estimated Study Completion Date:	October 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334646

Locations

United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8001
Sweden
GSK Investigational Site
LUND, Sweden, SE-221 85
United Kingdom
GSK Investigational Site
London, United Kingdom, EC1A 7BE
United Kingdom, Hampshire
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKV103444
Study First Received:	June 6, 2006
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00334646
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Chemotherapy induced nausea and vomiting
cyclophosphamide
CINV

Study placed in the following topic categories:

Vomiting
Nausea
Cyclophosphamide

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009