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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Chemotherapy-Induced, Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

throughout the study

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

NKV103444

NCT ID:

NCT00334646

Start Date:

August 2005

Completion Date:

September 2009

Related Keywords:

  • Nausea and Vomiting, Chemotherapy-Induced
  • Cancer
  • cyclophosphamide
  • CINV
  • Chemotherapy induced nausea and vomiting
  • Nausea
  • Vomiting

Name

Location
GSK Investigational Site New York, New York  10021
GSK Investigational Site Newark, Delaware  19713