A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 12
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.
详细描述
This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
- •measurable disease based on radiographic evaluation or elevated tumor markers.
- •ECOG - 0 or 1 (KPS >70).
- •Life expectancy > 3 months.
排除标准
- •chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
- •known active brain metastases or leptomeningeal carcinomatosis.
- •history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
- •clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.
研究组 & 干预措施
1
CGC-11047 in combination with Gemcitabine
干预措施: CGC-11047 and gemcitabine (Drug)
2
CGC-11047 in combination with Docetaxel
干预措施: CGC-11047 and docetaxel (Drug)
3
CGC-11047 in combination with Bevacizumab
干预措施: CGC-11047 and bevacizumab (Drug)
4
CGC-11047 in combination with Erlotinib
干预措施: CGC-11047 and erlotinib (Drug)
5
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
干预措施: CGC-11047 and cisplatin (Drug)
6
CGC-11047 in combination with 5-Flurouracil / Leucovorin
干预措施: CGC-11047 and 5-flurouracil / leucovorin (Drug)
7
CGC-11047 in combination with Sunitinib
干预措施: CGC-11047 and sunitinib (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: End of Study
The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT). DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047: 1. Any nonhematologic toxicity \> Grade 3 lasting \> 3 days 2. Grade 4 thrombocytopenia 3. Grade 4 Anemia on the next scheduled dosing day 4. Grade 4 Neutropenia (lasting \> than 5 days 5. Any febrile neutropenia (Grade 3 or 4)) 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
次要结局
- Drug Safety(Ongoing)
- Pharmacokinetics(End of Study)