Cyclophosphamide Drug Interaction Study In Cancer Patients
NCT ID: NCT00334646
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
25 participants
INTERVENTIONAL
2005-08-10
2009-10-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm A
cyclophosphamide + dexamethasone + ondansetron
IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Arm B
cyclophosphamide + dexamethasone + ondansetron + GW679769
Oral GW679769
150mg oral, once daily on days 1-3
Interventions
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Oral GW679769
150mg oral, once daily on days 1-3
IV Cyclophosphamide 500-700mg/m2
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Newark, Delaware, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Christchurch, , New Zealand
GSK Investigational Site
Lund, , Sweden
Countries
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Other Identifiers
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NKV103444
Identifier Type: -
Identifier Source: org_study_id