A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
2014年7月23日 更新者：Hoffmann-La Roche
An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy.
The anticipated time on study treatment is until disease progression.
調査の概要
研究の種類
介入
入学 (実際)
6
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。
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～75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:
- adult patients 18-75 years of age;
- metastatic or advanced gastric cancer;
- disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- >=1 measurable lesion;
- HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
- concurrent chemotherapy or immunotherapy;
- brain or meningeal metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- women who are pregnant or breastfeeding.
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：Trastuzumab Monotherapy
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
|
4 mg/kg initial dose, followed by 2 mg/kg
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
時間枠：Weekly throughout study
|
Tumor response assessed according to RECIST.
Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions.
Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD).
Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
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Weekly throughout study
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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 |
|---|---|---|
|
Percentage of Participants With Clinical Benefit
時間枠：Weekly throughout the study
|
Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD.
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable SD: not qualifying for CR, PR, or PD.
|
Weekly throughout the study
|
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Percentage of Participants With a Best Overall Response of CR or PR
時間枠：Weekly throughout the study
|
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
|
Weekly throughout the study
|
|
Overall Survival - Number of Participants Who Died
時間枠：Weekly throughout the study
|
OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
|
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Overall Survival
時間枠：Weekly throughout the study
|
Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
|
|
Time to Progression - Number of Participants With an Event
時間枠：Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
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Time to Progression
時間枠：Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
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
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
2004年1月1日
一次修了 (実際)
2008年2月1日
研究の完了 (実際)
2008年2月1日
試験登録日
最初に提出
2013年12月4日
QC基準を満たした最初の提出物
2013年12月4日
最初の投稿 (見積もり)
2013年12月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年8月11日
QC基準を満たした最後の更新が送信されました
2014年7月23日
最終確認日
2014年7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。
胃癌の臨床試験
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