Status:
COMPLETED
To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 saf...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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%.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
November 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00258050
Start Date
November 21 2005
End Date
February 8 2007
Last Update
December 6 2017
Active Locations (2)
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1
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
2
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599