To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients
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ClinicalTrials.gov Identifier: NCT00258050 |
Recruitment Status :
Completed
First Posted : November 24, 2005
Last Update Posted : December 6, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | ||||
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First Submitted Date ICMJE | November 22, 2005 | |||
First Posted Date ICMJE | November 24, 2005 | |||
Last Update Posted Date | December 6, 2017 | |||
Actual Study Start Date ICMJE | November 21, 2005 | |||
Actual Primary Completion Date | February 8, 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients. | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients | |||
Official Title ICMJE | A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients | |||
Brief Summary | To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neoplasms, Breast | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Subjects with cancer
In Part 1 of the study, subjects will be randomized to one of four sequences. All subjects will receive oral or intravenous (IV) midazolam on Days 1, 3, 9 and 11 as per assigned randomization scheme. Starting on Day 4 through Day 11, subjects will receive a daily dose of 1500 milligrams (mg) of oral lapatinib. In Part 2, which will begin on Day 12, the subjects will be required to take 1500 mg of lapatinib daily until removed from the study for disease progression, adverse events, withdrawal of consent, or transfer to another lapatinib study. Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
24 | |||
Original Enrollment ICMJE |
16 | |||
Actual Study Completion Date ICMJE | February 8, 2007 | |||
Actual Primary Completion Date | February 8, 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00258050 | |||
Other Study ID Numbers ICMJE | EGF10015 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | GlaxoSmithKline | |||
Study Sponsor ICMJE | GlaxoSmithKline | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |