NCT00789763已完成1 期
Open-label, Multicentric Phase I-II Trial to Evaluate the Efficacy and Safety of the Combination of Sorafenib (BAY 43-9006), Gemcitabine and Concurrent Radiotherapy, in Locally Advanced Pancreatic Carcinoma
Grupo Espanol Multidisciplinario del Cancer Digestivo4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年12月最近更新:
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
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- EFFICACY
研究概览
简要总结
Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy
Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response rate, Overall survival, Toxicity profile
详细描述
Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy
Definition of maximum tolerated dose (MTD):
The MTD is defined as the highest dose level which can be given to 6 patients such that no more than 1 patient experiences a DLT .
Definition of Recommended Dose (DR):
Is the MTD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients with histological or cytological confirmed locally advanced pancreatic adenocarcinoma pancreatic carcinoma or metastatic pancreatic carcinoma for phase I.
- •Patients with measurable (according to RECIST) disease.
- •Male or female patients > or = 18 years old
- •Adequate bone marrow, liver , and renal function: Absolute neutrophil count ( ANC) >= 1,500/mm3 Platelets> or = 100,000/µl Hemoglobin >=9.0 g/dl Total bilirubin < 1.5 x the upper limit of normal. ALT and AST <= 2.5 x upper limit of normal ( <= 5X upper limit of normal for patients with liver involvement ) Serum creatinine <= 1.5 times x the upper limit of normal. Patients with creatinine clearance >= 45mL/min PT( prothrombin time ) or INR( international normalized ratio ) and PTT ( partial thromboplastin time ) < =1.5 x
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib
- •Signed informed consent prior to any study specific procedures
排除标准
- •Patients with previous treatment for pancreatic carcinoma
- •PTV ( planning target volume ) >500 cm3 or 5 cm (maximum diameter)
- •Patients with known or suspected allergy to iodated contrasts or renal impairment which prevents from radiological tests.
- •Pregnant or nursing patients. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- •General medical or psychological conditions that would preclude appropriate informed consent or compliance with the protocol.
- •Previous cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry
- •Concurrent treatment with other experimental drugs (within 30 days prior to study entry).
- •Concurrent treatment with other anti-cancer therapy.
- •Therapeutic anticoagulation with Vitamin K antagonists such as warfarin or with heparins or heparinoids. Low dose warfarin is permitted if INR is <1.5 . Low dose aspirin is permitted .
- •Patients with any medical condition which could jeopardize their safety while his participation in the study .
- •Significant weight loss (> or equal 10% body weight during preceding 6 weeks)
- •Major surgery within 3 previous weeks, or laparoscopic biopsy or significant traumatic injury within 2 weeks of prior to first dose of study drug.
- •Known or suspected allergy to sorafenib or any agent given in the course of this trial .
- •Patients with evidence or history of bleeding diathesis or coagulopathy
- •Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
- •Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina or new-onset angina (began within the last 3 months) or myocardial infarction within the last 6 months
- •Patients with Child-Pugh class C hepatic impairment
- •Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis
- •Active clinically serious infections > CTCAE Grade 2
- •Serious, non-healing wound, ulcer, or bone fracture
- •Patients with concomitant ketoconazole, itraconazole,ritonavir,rifampicin or St. John's Wort (Hypericum perforatum).
- •Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
- •Any instable condition that may interfere with the patients participation in the study
研究组 & 干预措施
Sorafenib + gemcitabine + radiotherapy
Experimental
干预措施: Gemcitabine (Drug)
Sorafenib + gemcitabine + radiotherapy
Experimental
干预措施: Radiotherapy (Radiation)
Sorafenib + gemcitabine + radiotherapy
Experimental
干预措施: Sorafenib (Drug)
结局指标
主要结局
EFFICACY
时间窗: End of Study
TO DETERMINE MTD
时间窗: Treatment (5 weeks)
SAFETY
时间窗: End of Study
次要结局
- RESPONSE (ACCORDING TO RECIST)(End of Study)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Sorafenib Plus S-1 in Advanced Solid TumorsAdvanced Solid TumorsNCT01128998National Health Research Institutes, Taiwan30
已完成
1 期
Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 ChannelCancerNCT01578564Soricimed Biopharma Inc23
终止
1 期
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic MalignanciesWaldenstrom MacroglobulinemiaMultiple MyelomaNCT01416428Amgen210
撤回
1 期
Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)NCT00627835British Columbia Cancer Agency
终止
2 期
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic SyndromesMyelodysplastic SyndromesNCT02240706Boehringer Ingelheim27