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

2017年12月4日 更新者：GlaxoSmithKline

A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

24

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • New Hampshire
      • Lebanon、New Hampshire、アメリカ、03756
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Midazolam
Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.
他の名前：
  • GW572016 oral tablets
薬：Lapatinib
Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Area under the concentration versus time curve (AUC) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration. AUC of midazolam in the presence and absence of lapatinib will be determined.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Maximum observed concentration (Cmax) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration. Cmax of midazolam in the presence and absence of lapatinib will be determined.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Clearance (CL) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration. CL of midazolam in the presence and absence of lapatinib will be determined.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Half-life (t½) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration. t1/2 of midazolam in the presence and absence of lapatinib will be determined.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Absolute bioavailability (F) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration. Absolute bioavailability of midazolam in the presence and absence of lapatinib will be determined.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11

二次結果の測定

結果測定
メジャーの説明
時間枠
Time of maximum observed concentration (tmax) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Volume of distribution (Vss) of midazolam
時間枠：Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Blood samples will be collected at indicated time points for the determination of midazolam concentration.
Pre-dose, 2 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose on Day 1, Day 3, Day 9 and Day 11
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
時間枠：Up to Month 7
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events may require medical or surgical intervention to prevent one of the other outcomes listed above.
Up to Month 7
Number of subjects with abnormal clinical chemistry parameters
時間枠：Up to Month 7
The following clinical chemistry parameters were evaluated: sodium, potassium, total carbon dioxide (CO2), calcium, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN).
Up to Month 7
Number of subjects with abnormal hematology parameters
時間枠：Up to Month 7
The following hematology parameters were evaluated: hemoglobin, hematocrit, red blood cell count, white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count and basophil count.
Up to Month 7
Number of subjects with abnormal blood pressure
時間枠：Up to Month 7
Systolic and diastolic blood pressure will be measured.
Up to Month 7
Number of subjects with abnormal heart rate
時間枠：Up to Month 7
Heart rate will be measured.
Up to Month 7

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2005年11月21日

一次修了 (実際)

2007年2月8日

研究の完了 (実際)

2007年2月8日

試験登録日

最初に提出

2005年11月22日

QC基準を満たした最初の提出物

2005年11月23日

最初の投稿 (見積もり)

2005年11月24日

学習記録の更新

投稿された最後の更新 (実際)

2017年12月6日

QC基準を満たした最後の更新が送信されました

2017年12月4日

最終確認日

2017年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • EGF10015

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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