Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
2019年1月10日 更新者：Ipsen
A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
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。
研究場所
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Georgia
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Augusta、Georgia、アメリカ、30912
- Dept of Obstetrics and Gynecology, Medical College of Georgia
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Division of Gynecologic Oncology, University of Minnesota Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104-4283
- Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
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Upland、Pennsylvania、アメリカ、19103
- Crozer Chester Medical Center
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Ontario
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London、Ontario、カナダ、N6A 4L6
- London Health Sciences Centre, University of Western Ontario
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Ottawa、Ontario、カナダ、K1H 8L6
- Department of Oncology, Ottawa Cancer Center
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Toronto、Ontario、カナダ、M5G 2M9
- Dept of Obstetrics and Gynecology, Princess Margaret Hospital
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Quebec
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Montreal、Quebec、カナダ、H2L 4M1
- CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
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Montreal、Quebec、カナダ、H2W 1S6
- Department of Oncology, McGill University
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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:
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Exclusion Criteria:
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
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 |
|---|---|
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実験的：BN83495
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1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
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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 |
|---|---|---|
|
Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
時間枠：12 weeks
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CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
12 weeks
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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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Number of Participants With Adverse Events
時間枠：Up to 28 days after last dose
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Up to 28 days after last dose
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Determination of Time to Progression (TTP) in This Patient Population
時間枠：After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Progression Free Survival (PFS) in This Patient Population
時間枠：After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Response Rate (ORR) in This Patient Population
時間枠：After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Overall Response Rate (ORR): Defined as the sum of CR and PR.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Duration of Response in This Patient Population
時間枠：After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Survival in This Patient Population
時間枠：2 years after the last patient enrolled
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Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
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2 years after the last patient enrolled
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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
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
2010年11月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年7月1日
試験登録日
最初に提出
2010年11月23日
QC基準を満たした最初の提出物
2010年11月30日
最初の投稿 (見積もり)
2010年12月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月14日
QC基準を満たした最後の更新が送信されました
2019年1月10日
最終確認日
2019年1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。