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Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer

2014年11月6日 更新者：GlaxoSmithKline

A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer

This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.

研究の種類

介入

入学 (実際)

14

段階

  • フェーズ2

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
    • Arizona
      • Scottsdale、Arizona、アメリカ、85258
        • GSK Investigational Site
    • Florida
      • Fort Myers、Florida、アメリカ、33916
        • GSK Investigational Site
      • Orlando、Florida、アメリカ、32806
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge、Louisiana、アメリカ、70809
        • GSK Investigational Site
    • Minnesota
      • Duluth、Minnesota、アメリカ、55805
        • GSK Investigational Site
    • New York
      • Buffalo、New York、アメリカ、14263
        • GSK Investigational Site
    • Ohio
      • Columbus、Ohio、アメリカ、43219
        • GSK Investigational Site
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74136
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19106
        • GSK Investigational Site
      • Sayre、Pennsylvania、アメリカ、18840
        • GSK Investigational Site
    • Texas
      • Corpus Christi、Texas、アメリカ、78463-3069
        • GSK Investigational Site
    • Virginia
      • Newport News、Virginia、アメリカ、23601
        • GSK Investigational Site
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 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年歳以上 (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:

  • Signed consent
  • Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
  • Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
  • Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
  • 18 years of age or older.
  • Eastern Cooperative Oncology Group performance status of at least 2.
  • Measurable disease according to RECIST.
  • Adequate organ system function.
  • Females may be eligible to enroll if they are of non-childbearing potential (surgically sterile or post-menopausal)or are using appropriate contraception methods.

Exclusion Criteria:

  • Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
  • History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
  • Clinically significant gastrointestinal abnormalities.
  • Presence of uncontrolled infection.
  • Corrected QT interval greater than 480 msec.
  • History of significant cardiovascular condition(s).
  • Poorly controlled hypertension (systolic blood pressure of 140mmHG or greater or diastolic blood pressure of 90mmHg or greater).
  • History of cerebrovascular accident, pulmonary embolism, or insufficiently treated deep venous thrombosis within the past 6 months prior to first dose of study drug.
  • Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Active bleeding or diathesis.
  • Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
  • Serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures.
  • Use of prohibited medications as defined in protocol.
  • Use of an investigational agent, including an investigational anti-cancer agent within 28 days, or 5 half-lives, whichever is longer, prior to first dose of study drug.
  • Prior use of any investigational or licensed anti-angiogenic agent, including thalidomide and agents that target platelet-derived growth factor. Prior treatment with bevacizumab or epidermal growth factor receptor tyrosine kinase inhibitors

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：非ランダム化
  • 介入モデル：単一グループの割り当て
  • 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：Pazopanib Open-label
Single-arm, non-randomised, single-stage pazopanib monotherapy.
薬：Pazopanib (GW786034)
Pazopanib monotherapy

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
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria
時間枠：Baseline through End of Study (up to 2 years)
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Who Had a Complete or Partial Response, or Stable Disease
時間枠：Baseline through End of Study (up to 2 years)
Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)
Progression-Free Survival
時間枠：Baseline through End of Study (up to 2 years)
Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)
Overall Survival
時間枠：Baseline through End of Study (up to 2 years)
Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)
Levels of Circulating Biomarkers in Plasma
時間枠：Baseline through End of Study (up to 2 years)
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)
Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers
時間枠：Baseline through End of Study (up to 2 years)
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)

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

2008年2月1日

一次修了 (実際)

2009年4月1日

研究の完了 (実際)

2009年4月1日

試験登録日

最初に提出

2007年10月23日

QC基準を満たした最初の提出物

2007年10月23日

最初の投稿 (見積もり)

2007年10月25日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年11月19日

QC基準を満たした最後の更新が送信されました

2014年11月6日

最終確認日

2014年11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

  • 109609

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。

肺がん、非小細胞の臨床試験

Pazopanib (GW786034)の臨床試験

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