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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00334646




Registration number
NCT00334646
Ethics application status
Date submitted
6/06/2006
Date registered
8/06/2006
Date last updated
17/11/2017

Titles & IDs
Public title
Cyclophosphamide Drug Interaction Study In Cancer Patients
Scientific 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
Secondary ID [1] 0 0
NKV103444
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and Vomiting, Chemotherapy-Induced 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral GW679769
Treatment: Drugs - IV Cyclophosphamide 500-700mg/m2

Experimental: Arm A - cyclophosphamide + dexamethasone + ondansetron

Experimental: Arm B - cyclophosphamide + dexamethasone + ondansetron + GW679769


Treatment: Drugs: Oral GW679769
150mg oral, once daily on days 1-3

Treatment: Drugs: IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
throughout the study
Secondary outcome [1] 0 0
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
Timepoint [1] 0 0
throughout the study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2009
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Delaware
Country [2] 0 0
United States of America
State/province [2] 0 0
New Mexico
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
Sweden
State/province [5] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00334646
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00334646