Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment
An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
Primary Objective:
- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel
Secondary Objective:
- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
調査の概要
詳細な説明
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
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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Cambridge、イギリス、CB2 2QQ
- Investigational Site Number 826001
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Milano、イタリア、20133
- Investigational Site Number 380001
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Rotterdam、オランダ、3075 EA
- Investigational Site Number 528001
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Utrecht、オランダ、3584 CX
- Investigational Site Number 528002
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Barcelona、スペイン、08035
- Investigational Site Number 724001
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Bruxelles、ベルギー、1200
- Investigational Site Number 056002
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Gent、ベルギー、9000
- Investigational Site Number 056001
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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 :
- Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.
- Eastern Cooperative Oncology Group performance status 0 - 2
- Stable renal function
Patients must have adequate liver and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5x10^9/L
- Platelets ≥ 100x10^9/L
- Total bilirubin ≤ 1.0 x the institutions upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal
- Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal
- Patient may have a Grade 1 or less neurotoxicity at study entry.
- Life expectancy > 3 months
- Age ≥ 18 years old
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
- Having given written informed consent prior to any procedure related to the study
Exclusion criteria:
- Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- Active hepatitis
- Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
- Patients requiring dialysis during the study.
- History of hypersensitivity to docetaxel or polysorbate 80.
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- Known brain metastases.
- If female, pregnancy or breast-feeding.
- Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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:Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
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Pharmaceutical form: solution for infusion Route of administration: intravenous
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実験的:Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
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Pharmaceutical form: solution for infusion Route of administration: intravenous
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実験的:Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
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Pharmaceutical form: solution for infusion Route of administration: intravenous
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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 |
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Pharmacokinetic profile of cabazitaxel in study population
時間枠:Up to day 10
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Up to day 10
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二次結果の測定
結果測定 |
時間枠 |
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Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
時間枠:up to 30 days after the last dosing
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up to 30 days after the last dosing
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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
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
追加の関連 MeSH 用語
その他の研究ID番号
- POP12251
- 2011-001517-14 (EudraCT番号)
- U1111-1121-4512 (その他の識別子:UTN)
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。
Cabazitaxel XRP6258の臨床試験
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University of Alabama at BirminghamSanofi完了
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AIO-Studien-gGmbHSanofi; ClinAssess GmbH終了しました乳がん | 肺癌 | 再発性脳転移 | 進行性脳転移ドイツ
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Krzysztof MisiukiewiczSanofi; Icahn School of Medicine at Mount Sinai完了