Last updated: 11/07/2018 17:50:27
Cyclophosphamide Drug Interaction Study In Cancer Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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
Trial description: This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: throughout the study
Secondary outcomes:
Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
Timeframe: throughout the study
Interventions:
Drug: Oral GW679769
Drug: IV Cyclophosphamide 500-700mg/m2
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Laurel Adams, Brendan Johnson, Sharon Murray. A pharmacokinetic, pharmacodynamic, and safety study of intravenous cyclophosphamide with an oral casopitant antiemetic regimen in cancer patients. Clin Pharmacol Drug Devel. 2013;
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
August 2005 to October 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Pregnant or lactating.
- CNS (central nervous system) metastases.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2009-14-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study NKV103444 can be found on the GSK Clinical Study Register.
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