NCT00606125已完成1 期
Phase I Study With Sorafenib in Combination With Carboplatin and Paclitaxel to Evaluate the Safety and Pharmacokinetics of This Combination in Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks
研究概览
简要总结
The purpose of this study is to:
- Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
- Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
- To determine the safety of sorafenib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age > or equal to 18 years
- •Histological or cytological documentation of cancer, except non small cell lung cancer
- •ECOG Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks
- •No more than two prior chemotherapy regimens
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin > or equal to 9.0 g/dL
- •Absolute neutrophil count (ANC) > or equal to 1,500/mm3
- •Platelet count > or equal to 100,000/mm3
- •Total bilirubin < or equal to 1.25 times the ULN
- •ALT and AST < or equal to 2.5 x ULN
- •PT-INR/PTT < 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or low molecular weight heparin or therapeutically anticoagulated with LMWH will be allowed to participate provided that they meet these criteria; in addition, these patients must be monitored at appropriate intervals throughout study)
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 day period after last study drug dosing. The investigator should advise the patient regarding adequate means of contraception.
- •Serum creatinine < or equal to 1.5 x upper limit of normal
- •Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
排除标准
- •Clinically evident congestive heart failure > NYHA Class 2 (See Appendix 10.4)
- •Serious cardiac arrhythmias (for example requiring anti-arrhythmics)
- •Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- •Active clinically serious infections (> Grade 2 NCI-CTC)
- •Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment with dexamethasone, the patient is not on anticoagulant therapy and whose radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria:
- •Stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery ≥ 4 weeks from first study treatment
- •Neurosurgery ≥ 24 weeks from first study treatment
- •Brain biopsy ≥ 12 weeks from first study treatment
- •History of organ allograft
- •Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- •Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Peripheral neuropathy > or equal to Grade 2
- •Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to Screening
- •Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first study treatment
- •Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first study treatment
- •Evidence or history of bleeding diathesis or coagulopathy
- •Serious, non-healing wound, ulcer, or bone fracture
- •Patients undergoing renal dialysis
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
- •Previous cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 3 years prior to first study treatment
- •Non small cell lung cancer
- •Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Pregnant or breast-feeding patients.
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •Any condition that impairs patient's ability to swallow whole pills
- •Any malabsorption condition
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
结局指标
主要结局
Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks
时间窗: 2 years
次要结局
- To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.(2 years)
研究者
相似试验
已完成
1 期
Sorafenib/Docetaxel Dose Escalation TrialNeoplasmsNCT00562523Bayer17
已完成
1 期
Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion ChemotherapyHepatocellular CarcinomaNCT00933816Kindai University37
已完成
1 期
Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal CancerRecurrent Colon CancerRecurrent Rectal CancerStage III Colon CancerStage III Rectal CancerStage IV Colon CancerStage IV Rectal CancerNCT00134069National Cancer Institute (NCI)48
终止
1 期
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate CancerProstate CancerNCT00924807Beth Israel Medical Center4
终止
1 期
Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian CancerOvarian CancerNCT00526799Daniela Matei, MD30