ST1968 Intravenous (Weekly) in Solid Tumors
Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors
調査の概要
詳細な説明
Multicenter, open label, uncontrolled Phase I pharmacokinetic trial to determine the Maximum Tolerated Dose (MTD) of ST1968 given intravenously (I.V.) once every week for 2 consecutive weeks every 3 weeks and the MTD of ST1968 given I.V. once every 3 weeks. A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule.
Plasma, urine pharmacokinetics in all patients (minimum of 3 pts for each cohort) during the first cycle of treatment and in at least 6 patients at the Recommended Dose (RD).
During the study any hints of anti-tumor activity will also be evaluated by RECIST criteria.
研究の種類
入学 (実際)
段階
- フェーズ 1
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:
- Histological/cytological diagnosis of solid tumors for which therapy of proven efficacy does not exist.
- Preferably measurable disease
- ECOG performance status ≤ 1.
- Age ≥ 18 years.
- Ongoing toxicity associated with prior anticancer therapy ≤ grade 1 (NCI-CTCAE V3.0).
- Maximum of 2 prior chemotherapy lines for advanced disease (not including neoadjuvant or adjuvant chemotherapy)
- Adequate hematological, liver and renal function
- Hemoglobin ≥ 9 g/dl; ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L;
- Serum bilirubin ≤ upper normal limit (UNL). ALT, AST ≤ UNL but ≤ 2.5 x UNL in case of liver metastases; alkaline phosphatase (liver isoenzyme fraction) ≤ UNL or ≤ 1.5xULN in case of liver metastases; albumin within normal limits;
- Creatinine ≤1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min.
- Life expectancy of at least 3 months
- Capacity of understanding the nature of the trial and giving written informed consent.
Exclusion Criteria:
- Less than 4 weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than 2 weeks since last hormone or immunotherapy or signal transduction therapy.
- Active infection.
- Presence of cirrhosis or chronic hepatitis
- Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
- Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- Symptomatic brain metastases (this does not include primary brain tumors) or leptomeningeal disease.
- Pregnancy or lactation or unwillingness to use adequate method of birth control
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：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 |
|---|---|
|
実験的：ST1968
ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks -------------------------------------------------------------------------------- |
ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks
他の名前：
|
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 |
|---|---|---|
|
Maximum Tolerated Dose (MTD) of ST1968 given I.V. once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given I.V. once every 3 weeks
時間枠：21 days
|
2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)
|
21 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability
時間枠：21 days of each cycle of therapy
|
safety assessments (routine physical examinations and laboratory evaluations) and severity of adverse events based on the NCI-Common Terminology Criteria for Adverse Events V. 3.0 (NCI-CTCAE)
|
21 days of each cycle of therapy
|
|
Tumor response
時間枠：4 weeks
|
objective tumor response based on RECIST criteria
|
4 weeks
|
|
Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL
時間枠：21 days
|
full blood and urine PK
|
21 days
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Dagmar Hess, MD、Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ST1968-DM-06-001
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固形腫瘍の臨床試験
-
AstraZeneca積極的、募集していないAdv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃がん、乳がん、卵巣がんアメリカ, フランス, イギリス, 韓国