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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 16, 2006 | ||||
| Last Updated Date | June 27, 2008 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected [ Time Frame: Days 1 through 5 and Day 8 of Cycles 1 and 2 ] | ||||
| Original Primary Outcome Measures ICMJE |
To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected on Days 1 through 5 and Day 8 of Cycles 1 and 2 | ||||
| Change History | Complete list of historical versions of study NCT00388557 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected [ Time Frame: weekly ] | ||||
| Original Secondary Outcome Measures ICMJE |
Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected weekly. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Ketoconazole on the Pharmacokinetics of Vinflunine | ||||
| Official Title ICMJE | Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer | ||||
| Brief Summary | The purpose of the study is to test how ketoconazole affects with handling of vinflunine by the body which might affect how much vinflunine is in the blood stream and for how long |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study | ||||
| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Drug: vinflunine + ketaconazole | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00388557 | ||||
| Responsible Party | Study Director, Bristol-Myers Squibb | ||||
| Study ID Numbers ICMJE | CA183-009 | ||||
| Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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