ST1968 Intravenous (Weekly) in Solid Tumors
关键词
抽象
描述
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.
日期
| 最后验证: | 05/31/2012 |
| 首次提交: | 06/11/2012 |
| 提交的预估入学人数: | 12/09/2012 |
| 首次发布: | 12/11/2012 |
| 上次提交的更新: | 12/09/2012 |
| 最近更新发布: | 12/11/2012 |
| 实际学习开始日期: | 05/31/2007 |
| 预计主要完成日期: | 05/31/2011 |
| 预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Drug: ST1968
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: ST1968 ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks
-------------------------------------------------------------------------------- | Drug: ST1968 ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. 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 [21 days]
次要成果指标
1. Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability [21 days of each cycle of therapy]
2. Tumor response [4 weeks]
3. Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL [21 days]
