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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00258050
First received: November 22, 2005
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: GW572016 oral tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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: 16
Study Start Date: November 2005
Intervention Details:
    Drug: GW572016 oral tablets
    Other Name: GW572016 oral tablets
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258050

Locations
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00258050     History of Changes
Other Study ID Numbers: EGF10015
Study First Received: November 22, 2005
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lapatinib
midazolam
pharmacokinetics

Additional relevant MeSH terms:
Midazolam
Lapatinib
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014