To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Completed · Phase 1

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT00258050

Run by

GlaxoSmithKline

People needed

24

Starts

2005-11-21

Expected to finish

2007-02-08

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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