An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
2013年12月5日 更新者：Boehringer Ingelheim
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
調査の概要
研究の種類
介入
入学 (実際)
50
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
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Berlin、ドイツ
- 1200.10.49005 Boehringer Ingelheim Investigational Site
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Düsseldorf、ドイツ
- 1200.10.49007 Boehringer Ingelheim Investigational Site
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Erlangen、ドイツ
- 1200.10.49008 Boehringer Ingelheim Investigational Site
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Essen、ドイツ
- 1200.10.49010 Boehringer Ingelheim Investigational Site
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Kiel、ドイツ
- 1200.10.49003 Boehringer Ingelheim Investigational Site
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Mainz、ドイツ
- 1200.10.49004 Boehringer Ingelheim Investigational Site
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München、ドイツ
- 1200.10.49001 Boehringer Ingelheim Investigational Site
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Wiesbaden、ドイツ
- 1200.10.49006 Boehringer Ingelheim Investigational Site
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Brussel、ベルギー
- 1200.10.3208 Boehringer Ingelheim Investigational Site
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Bruxelles、ベルギー
- 1200.10.3201 Boehringer Ingelheim Investigational Site
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Charleroi、ベルギー
- 1200.10.3203 Boehringer Ingelheim Investigational Site
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Gent、ベルギー
- 1200.10.3205 Boehringer Ingelheim Investigational Site
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Leuven、ベルギー
- 1200.10.3204 Boehringer Ingelheim Investigational Site
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Wilrijk、ベルギー
- 1200.10.3206 Boehringer Ingelheim Investigational Site
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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
女性
説明
Inclusion criteria:
Inclusion Criteria:
- Female patients age 18 years or older
- Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- At least one measurable tumour lesion (RECIST);
- Availability of tumour samples
- Written informed consent that is consistent with ICH-GCP guidelines and local law
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.
Exclusion criteria:
Exclusion Criteria:
- Active infectious disease
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- Active/symptomatic brain metastases
- Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
- ANC less than 1500/mm3 platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
- AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
- Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast-feeding
- Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
- Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
- Active alcohol or drug abuse
- Other malignancy within the past 5 years
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：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：BIBW 2992
high dose once daily
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high dose once daily
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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 |
|---|---|---|
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Objective Response (OR)
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST).
OR was primary endpoint only for Cohort B.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Clinical Benefit (CB)
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was primary endpoint only for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Benefit (CB)
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Time to OR
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Progression-free Survival (PFS)
時間枠：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first.
It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment.
Median time results from unstratified Kaplan-Meier estimates.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Overall Survival (OS)
時間枠：From randomisation to end of follow-up.
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OS is defined as time from randomisation to death.
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From randomisation to end of follow-up.
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Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
時間枠：Baseline and last assessment
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LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan.
MUGA scan is an useful noninvasive tool for assessing the function of the heart.
Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
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Baseline and last assessment
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Best Change From Baseline in ECOG Performance Status
時間枠：baseline till end of treatment
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Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status.
ECOG is measured as score between 0 (fully active) and 5 (dead).
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baseline till end of treatment
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Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
時間枠：day 29
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Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
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day 29
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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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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
2006年11月1日
一次修了 (実際)
2009年5月1日
試験登録日
最初に提出
2007年1月22日
QC基準を満たした最初の提出物
2007年1月22日
最初の投稿 (見積もり)
2007年1月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年12月31日
QC基準を満たした最後の更新が送信されました
2013年12月5日
最終確認日
2013年8月1日
詳しくは
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。