Understanding Mechanisms of Acquired Resistance to BIBW2992
2018年3月5日 更新者：Lecia V. Sequist、Massachusetts General Hospital
In this research study we are looking to see how effective BIBW 2992 is at suppressing the development of the T790M mutation in non-small cell lung cancer (NSCLC) patients.
Epidermal growth factor receptors (EGFR) are proteins found on the surface of some cancer cells that promote a growth signal.
Some cancer drugs for NSCLC work to block this signal from reaching its target on the cancer cells which in turn may slow or stop the cancer from growing.
However, many times patients with EGFR mutations will stop responding to these cancer drugs and develop drug-resistance because they have developed a specific EGFR mutation called T790M.
BIBW 2992 may prevent the T790M mutation from becoming active and therefore slow disease progression.
調査の概要
詳細な説明
- Participants will take tablets of BIBW 2992 once a day during each cycle. Each cycle is 28 days (4 weeks).
- Participants will come to the clinic on Day 1, 8 and 15 of Cycle 1. For Cycle 2 through 8, they will need to come to the clinic on Day 1. After Cycle 8, they will have study visits every 2 months.
- The following tests and procedures will be performed at these clinic visits: physical examination, routine blood tests, research blood samples, EKG (every fourth cycle starting cycle 5), ECHO or MUGA (every fourth cycle starting cycle 5), an assessment of the tumor by CT or MRI scan (every 8 weeks).
- Participants may continue to participate in this research study as long as their tumor does not grow and their disease does not worsen and they do not have any severe side effects.
- Participants will have a tumor biopsy performed at the end of their participation in this study if their tumor is growing or if they have a new tumor. The purpose of this biopsy is to assess for the presence or the absence of the mutation T790M.
研究の種類
介入
入学 (実際)
24
段階
- 適用できない
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
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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
全て
説明
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed stage IIIB, IV or recurrent non-small cell lung cancer
- A somatic mutation in epidermal growth factor receptor (EGFR) must be present as documented by a CLIA-certified laboratory
- There must be radiographic measurable or evaluable disease
- Participants must be willing, at the time of signing consent, to agree to a future biopsy of their tumor tissue at the time of disease progression, provided such a biopsy is safe and feasible at that time.
- Performance status must be 0, 1 or 2 on the Eastern Cooperative Oncology Group scale
- 18 years of age or older
- Normal organ and marrow function as outlined in the protocol
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria:
- Prior EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, or any experimental EGFR TKI agents)
- Known brain metastases, unless they have undergone definitive therapy and are neurologically stable at the time of study entry
- Standard chemotherapy or radiation less than 2 weeks of starting BIBW 2992, or experimental systemic cancer therapy less then 4 weeks of starting BIBW 2992. Note that prior palliative radiation to bony disease, CNS disease, or a limited thoracic area is allowed if there is measurable or progressive disease outside the field of radiation.
- Another malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer)
- Known pre-existing and clinically active interstitial lung disease
- Significant gastrointestinal disorders with diarrhea as a major symptom
- History of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, or myocardial infarction within 6 months
- Cardiac left ventricular function with resting ejection fraction <50%
- Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug
- Pregnancy or breast feeding
- History of allergic reactions attributed to compounds of similar chemical or biologic composition of BIBW 2992
- Life expectancy of < 12 weeks
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：なし
- 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：BIBW 2992
BIBW 2992 Taken orally once a day
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Taken orally once a day
他の名前：
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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 |
時間枠 |
|---|---|
|
Number of Participants That Have a T790M Mutation on Their Progression Biopsy.
時間枠：At the time of disease progression (median duration of 11.4 months from start of treatment)
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At the time of disease progression (median duration of 11.4 months from start of treatment)
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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 |
|---|---|---|
|
Response Rate
時間枠：Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months
|
The number of participants with either a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months
|
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Median Progression-free and Overall Survival
時間枠：start of treatment, at the time of disease progression, time of death
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The progression-free and overall survival times.
Overall survival is measured from the start of treatment until the time of death or until the participant is lost to follow-up.
Progression free survival is measured from the start of treatment until the time of progression, death, or until the participant is lost to follow-up (whichever occurs first).
Progression is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions.
The appearance of one or more new lesions denotes disease progression.
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start of treatment, at the time of disease progression, time of death
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Number of Participants With Biopsy Complications From Repeat Tumor Biopsies
時間枠：7 days post biopsy and ≥ 30 days post-biopsy
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The number of participants with biopsy complications from repeat tumor biopsies taken following disease progression.
Biopsy complications are any adverse events considered to be potentially related to the biopsy.
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7 days post biopsy and ≥ 30 days post-biopsy
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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。
捜査官
- 主任研究者：Lecia V. Sequist, MD, PhD、Massachusetts General Hospital
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
2011年2月1日
一次修了 (実際)
2017年3月1日
研究の完了 (実際)
2017年3月1日
試験登録日
最初に提出
2010年2月22日
QC基準を満たした最初の提出物
2010年2月22日
最初の投稿 (見積もり)
2010年2月24日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月9日
QC基準を満たした最後の更新が送信されました
2018年3月5日
最終確認日
2018年3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。