Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.
The purpose of this study Part B is:
Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in 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
研究場所
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
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New York
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New York、New York、アメリカ、10032
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South Carolina
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Charleston、South Carolina、アメリカ、29425
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Singapore、シンガポール、119228
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Singapore、シンガポール、169610
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Taipei、台湾、10002
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Seoul、大韓民国、110-744
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Seoul、大韓民国、120-752
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Seoul、大韓民国、05505
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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:
- Male or female subjects aged >/=21 years
- Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
- Expansion phase only: Subjects with advanced, histologically or cytologically confirmed gastric cancer, triple negative breast cancer (TNBC), or diffuse large B-cell lymphoma (DLBCL), who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
- Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug
- International normalized ratio (INR) and partial thromboplastin time (PTT) </=1.5 times ULN (upper limit of normal)
Exclusion Criteria:
- Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
- History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
- Previous pulmonary embolism within 12 months prior to study entry
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
- Known history of human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C, requiring antiviral therapy
- Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent
- Uncontrolled seizure disorder requiring therapy (such as steroids or anti-epileptics with significant CYP interaction)
- Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of > Grade 2 within 4 weeks prior to the first dose of study drug
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:BAY1143572 [continuous]
BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously
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実験的:BAY1143572 [on/off]
BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule
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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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安全性と忍容性の尺度としての有害事象のある参加者の数
時間枠:2年まで
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2年まで
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Maximum tolerated dose (MTD) of BAY1143572
時間枠:Up to 1 year
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In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.
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Up to 1 year
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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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Maximum total drug concentration (Cmax)
時間枠:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)
時間枠:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Area under the plasma concentration-time curve from time zero to infinity (AUC)
時間枠:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Time of maximum observed concentration (tmax)
時間枠:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Tumor response based on RECIST 1.1 or Cheson 2007 criteria
時間枠:Up to 100 weeks
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Up to 100 weeks
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Biomarker evaluation by determination of MYC protein expression and PCNA mRNA
時間枠:Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
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PCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic acid
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Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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