or
forgot password

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

Thank you

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