AS703569 and Gemcitabine Combination in Advanced Malignancies
A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions:
Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment.
Male or female with at least 18 years of age. Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
No more than 3 prior chemotherapy regimens for advanced/metastatic disease.
At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged.
Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by:
Serum creatinine
研究計画
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：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：Regimen 1: AS703569/gemcitabine
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle
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Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
他の名前：
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
他の名前：
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実験的：Regimen 2: AS703569/gemcitabine
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle
|
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
他の名前：
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
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 |
|---|---|---|
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Maximum tolerated dose (MTD)
時間枠：21 days
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To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.
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21 days
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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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Treatment-emergent adverse events (TEAE)
時間枠：Minimum 21 days or 1 cycle
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Proportion/number of subjects with TEAE's during the first and subsequent treatment cycles in each cohort for each of the 2 regimens.
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Minimum 21 days or 1 cycle
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Progression-Free Survival (PFS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
時間枠：Variable
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PFS time is defined as time (in months) from first drug intake to date of progression as reported and documented by the investigator (i.e.
radiological progression per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or death from any cause.
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Variable
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Time to Tumor Progression (TTP) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
時間枠：Variable
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TTP time is defined as the time (in months)from first drug intake to the date of progression, as reported and documented by the Investigator (i.e.
radiological progression per RECIST).
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Variable
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Overall Survival (OS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
時間枠：Variable
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OS time is defined as the time (in months) from first drug intake to any cause of death.
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Variable
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Progressive disease (PD)
時間枠：Every other cycle
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Proportion of patients with progressive disease as assessed at the end of every other cycle according to disease-specific guidelines
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Every other cycle
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Best overall response (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
時間枠：Every other cycle
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For subjects with locally advanced /metastatic pancreatic cancer: Best overall response: presence of at least one confirmed Complete Response (CR) or confirmed Partial Response (PR) (using RECIST v1.0) during treatment in the 2 regimens as assessed at the end of every other cycle. |
Every other cycle
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協力者と研究者
捜査官
- スタディディレクター：Narmyn Rejeb, MD、Merck Serono S.A., Geneva
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 27902
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