Back to resultsCyclophosphamide Drug Interaction Study In Cancer Patients
Primary Purpose
Nausea and Vomiting, Chemotherapy-Induced
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oral GW679769
IV Cyclophosphamide 500-700mg/m2
Sponsored by
About this trial
This is an interventional treatment trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
cyclophosphamide + dexamethasone + ondansetron
cyclophosphamide + dexamethasone + ondansetron + GW679769
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00334646
Brief Title
Cyclophosphamide Drug Interaction Study In Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
compound terminated
Study Start Date
August 10, 2005 (Actual)
Primary Completion Date
October 14, 2009 (Actual)
Study Completion Date
October 14, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Chemotherapy-Induced
Keywords
cyclophosphamide, CINV, Chemotherapy induced nausea and vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
cyclophosphamide + dexamethasone + ondansetron
Arm Title
Arm B
Arm Type
Experimental
Arm Description
cyclophosphamide + dexamethasone + ondansetron + GW679769
Intervention Type
Drug
Intervention Name(s)
Oral GW679769
Intervention Description
150mg oral, once daily on days 1-3
Intervention Type
Drug
Intervention Name(s)
IV Cyclophosphamide 500-700mg/m2
Other Intervention Name(s)
Oral GW679769
Intervention Description
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Cyclophosphamide Drug Interaction Study In Cancer Patients
We'll reach out to this number within 24 hrs