Cyclophosphamide Drug Interaction Study In Cancer Patients

November 13, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8011
        • GSK Investigational Site
  • Sweden
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site
  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
cyclophosphamide + dexamethasone + ondansetron
Drug: IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Other Names:
  • Oral GW679769
Experimental: Arm B
cyclophosphamide + dexamethasone + ondansetron + GW679769
Drug: Oral GW679769
150mg oral, once daily on days 1-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2005

Primary Completion (Actual)

October 14, 2009

Study Completion (Actual)

October 14, 2009

Study Registration Dates

First Submitted

June 6, 2006

First Submitted That Met QC Criteria

June 6, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV103444

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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