To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients
This study has been completed.
Information provided by:
First received: November 22, 2005
Last updated: October 9, 2008
Last verified: October 2008
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.
Drug: GW572016 oral tablets
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- To assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed, solid tumor refractory to standard therapy.
- Tumor for which there is no standard therapy.
- Able to swallow and retain oral medication.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
- Provided written informed consent.
- Adequate bone marrow function.
- Serum creatinine is less than or equal to 1.5 mg/dL.
- Calculated creatinine clearance is greater than or equal to 60 ml/min based on Cockcroft and Gault.
- Total bilirubin is greater than or equal to the upper limit of normal of institutional values.
- Aspartate and alanine transaminase is less than or equal to 3 times the upper limit of the institutional values.
- Have a left ventricular ejection fraction (LVEF) greater than or equal to 40% based on electrocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- Resting oxygen saturations of greater than 90%.
- Pregnant or lactating female.
- Have malabsorption syndrome, a disease affecting gastrointestinal function.
- Resection of the stomach or small bowel.
- Evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product.
- Use of anilinoquinazolines, such as gefitinib [Iressa™], erlotinib [Tarceva™].
- Immediate or delayed hypersensitivity reaction to midazolam or any component of the formulation, including benzyl alcohol (cross-sensitivity with other benzodiazepines may exist).
- Has narrow-angle glaucoma which is a contraindication to midazolam use.
- Has received treatment with any investigational drug in the previous 4 weeks.
- Received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days, with the exception of mitomycin C within the past 6 weeks.
- Currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.
- Is taking regular doses of opiates that in the opinion of the investigator would put the patient at risk of clinically significant respiratory compromise when midazolam is administered.
- Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Has Class II to IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Clinically significant electrocardiogram (ECG) abnormality.
- Clinically assessed to have inadequate venous access for protocol-related blood draws.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00258050
|GSK Investigational Site
|Lebanon, New Hampshire, United States, 03756 |
|GSK Investigational Site
|Chapel Hill, North Carolina, United States, 27599 |
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 22, 2005
||October 9, 2008
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on March 26, 2015