NCT00334646

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1

Geographic Reach
3 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2009

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

June 6, 2006

Last Update Submit

November 13, 2017

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Keywords

cyclophosphamideCINVChemotherapy induced nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • 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.

    throughout the study

Secondary Outcomes (1)

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

    throughout the study

Study Arms (2)

Arm A

EXPERIMENTAL

cyclophosphamide + dexamethasone + ondansetron

Drug: IV Cyclophosphamide 500-700mg/m2

Arm B

EXPERIMENTAL

cyclophosphamide + dexamethasone + ondansetron + GW679769

Drug: Oral GW679769

Interventions

Oral GW679769DRUG

150mg oral, once daily on days 1-3

Arm B
IV Cyclophosphamide 500-700mg/m2DRUG

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

Also known as: Oral GW679769
Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Newark, Delaware, 19713, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Christchurch, 8011, New Zealand

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

Related Links

MeSH Terms

Conditions

NauseaVomiting

Interventions

casopitantCyclophosphamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 8, 2006

Study Start

August 10, 2005

Primary Completion

October 14, 2009

Study Completion

October 14, 2009

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

NZ(1)US(3)SE(1)