EUCTR2006-003403-39-DE进行中（未招募）不适用
Combination of antiangiogenic therapy using the mTOR-inhibitor RAD001 and low dose chemotherapy for locally advanced and/or metastatic pancreatic cancer – a dose finding study
ovartis Pharma GmbH0 个研究点开始时间: 2007年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histological confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
- •2. compliant patient, regular follow-up possible
- •3. Adequate bone marrow, liver and renal function on RAD001 treatment, as shown by:
- •WBC equal or higher than 3 x 109/L
- •Absolute neutrophil count (ANC) equal or higher than 1.5 x 109/L
- •Hemoglobin equal or higher than 9 g/dL
- •Platelet count equal or higher than 100 x 109/L
- •Serum transaminase activity (AST/SGOT & ALT/SGPT) < 2.5 X ULN oder 3 x ULN with the exception of serum transaminases (< 5 x ULN) if the patient has liver metastases
- •Serum total bilirubin < 2.5 x ULN
- •Serum creatinine < 1.5 x ULN or a creatinine clearance of equal or higher than 60 mL/min.
- •4. At least one measurable lesion (longest diameter equal or higher than 20 mm on conventional CT or MRI scan; equal or higher than 10 mm on spiral CT) according to RECIST criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. The scans should be approximately 2 weeks old to be used as baseline scan.
- •5. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).
- •6. ECOG Performance Status 0-2 (Post Text Supplement 2)
- •7. Age = 18 years
- •8. Signed informed consent must be obtained prior to any screening procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
- •2. Documented intolerance or history of allergy to RAD001 or Gemcitabine
- •3. Patients with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
- •4. Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g. known HIV infection, uncontrolled diabetes, chronic or acute renal or liver disease, uncontrolled infections including abscess or fistulae, fibrosis of the lung serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV (Post Text Supplement 4))
- •5. Use of other investigational cancer therapies within 28 days prior to enrollment or which are currently being or planned to be received during the course of the study
- •6. Patients presenting with known or symptomatic CNS metastases or leptomeningeal involvement
- •7. Chronic treatment with systemic steroids or another immunosuppressive agent
- •8. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- •9. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value < 50 % or PTT more than 1,5 fold higher
- •10. Patients who have received prior treatment with an mTor inhibitor
- •11. Patients who have received a prior treatment with Gemcitabine. Only adjuvant treatment with Gemcitabine is allowed. Interval between treatment and relapse should be 3 months minimum
- •12. History of noncompliance to medical regimens
- •13. Patients unwilling to or unable to comply with the protocol
- •14. Patients committed to an institution by order of the authorities or court decision
研究者
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